Biometric, physiological or environmental monitoring using a closed chamber

ABSTRACT

An aural iris includes a lumen and an actuator coupled on or in or to the lumen for at least partially attenuating sound traversing through the lumen by selectively actuating the actuator on and off. Other embodiments are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This Application is a provisional utility patent application that claimsthe priority benefit of Provisional Patent Application No. 62/090,136entitled “MEMBRANE AND BALLOON SYSTEMS AND DESIGNS FOR CONDUITS” filedon Dec. 10, 2014, and further claims the priority benefit of ProvisionalPatent Application No. 62/158,740 entitled “BIOMETRIC, PHYSIOLOGICAL ORENVIRONMENTAL MONITORING USING A CLOSED CHAMBER” filed on May 8, 2015the entire contents of which are both incorporated herein by referencein their entirety.

FIELD

The embodiments relate generally to monitoring of health or other statusinformation and, more particularly, to health or status monitoring usinga device such as a communication device within a sealed or substantiallysealed conduit or cavity.

BACKGROUND

Integration of functions within a communication device has seen theincorporation of cameras, calendars, browsers and an ever-growing numberof applications for a myriad number of purposes. The basic functionalityof a communication device such a phone still remains to capture,transmit and receive voice and other data communications. Unfortunately,the process of capturing voice or data using today's devices is subjectto a significant amount of noise, interference, or corruption affectingsignal quality. There is growing market demand for personal health andenvironmental monitors, for example, for gauging overall health andmetabolism during exercise, athletic training, dieting, and physicaltherapy. However, traditional health monitors and environmental monitorsmay be bulky, rigid, expensive, subject to inaccuracies, anduncomfortable. Existing traditional health monitors are generally notsuitable for use during daily physical activity. There is also growinginterest in wearable devices and generating or comparing health andenvironmental exposure information while still providing forintelligible and reliable high quality communications. However, currentmethods of collecting such health and environmental information may beexpensive and laborious, often utilizing human-based recording/analysissteps at multiple sites and the communication resources used forcollecting and transmitting such information remains subject tounacceptable levels of noise, interference, or corruption to the pointof making many such efforts fruitless and frustrating for a significantnumber of users. Unacceptable signal quality in harvesting andcommunicating both voice and data information will continue to hinderthe health, fitness, wearable, communications and other relatedindustries until an adequate solution is put forward.

BRIEF DESCRIPTION OF THE FIGURES

The embodiment and the following detailed description of certainembodiments thereof may be understood by reference to the followingfigures:

FIG. 1A and FIG. 1B are block diagrams of a telemetric monitoring devicefor physiological and/or environmental monitoring and personalcommunication, according to some embodiments herein.

FIGS. 2A-J are various perspective, front, rear, top, bottom, and sideviews of a portable telemetric monitoring device, such as the devicerepresented in FIGS. 1A or 1B, according to some embodiments herein.

FIG. 2K is a left rear perspective view of the device of FIGS. 2A-Jshown without an end cap in accordance with some embodiments herein.

FIG. 2L is a left rear perspective exploded view of the device of FIG.2K without a flange shown but with an end cap shown instead inaccordance with some embodiments herein.

FIGS. 2M and 2N are respectively a left rear perspective view and aright front perspective view of some of the internal components of thedevice of FIGS. 2A-K.

FIG. 3 is a perspective close up view of the rear portion of the deviceof FIGS. 2A-N without the end cap shown.

FIGS. 4A and 4B are left front perspective views of an earpiece that iswired rather than wireless in accordance with an embodiment. Note thatFIG. 4A illustrates some of the internal components of the device.

FIG. 5A is a left front perspective exploded view of the device of FIG.2 in accordance with an embodiment illustrating some internalcomponents.

FIG. 5B is a left front perspective exploded view of the device of FIG.2 in accordance with an embodiment shown without any opacity.

FIG. 5C is a right front perspective exploded view of the device of FIG.2.

FIG. 6A and FIG. 6B are left front perspective views of an earpiece inaccordance with an embodiment where FIG. 6A is partially shaded oropaque to show some internal components.

FIG. 6C is left front perspective view of some of the internalcomponents and end cap of the device of FIGS. 6A and 6B.

FIG. 6D is a right side view of the end cap of FIGS. 6A and 6B.

FIG. 6E is a plan view of the end cap of FIG. 6A or 6B with a capacitivetouch element shown and dimple boundary areas shown in accordance withan embodiment.

FIG. 7A and FIG.7B are left front perspective exploded views of anearpiece in accordance with an embodiment.

FIG. 8A is a left front perspective view of another earpiece inaccordance with an embodiment.

FIG. 8B is a left side view of the embodiment of FIG. 8A.

FIG. 8 C is a left front perspective exploded view of the earpiece ofFIGS. 8A and 8B.

FIGS. 8D through 8F illustrate various embodiments of an aural iris.

FIGS. 8G through 8O illustrate various actuators that can be used withthe aural iris of FIG. 8C, 8D, 8E, or 8F according to some of theembodiments herein.

FIG. 9 illustrates a graphical user interface for displaying data,according to some embodiments herein.

FIGS. 10A and 10B illustrate left and right earpiece modules accordingto some embodiments herein.

FIGS. 11A-11B illustrates an earpiece module with an adjustablemouthpiece for monitoring physiological and environmental informationnear the mouth, according to some embodiments herein, wherein FIG. 11Aillustrates the mouthpiece in a stored position and wherein FIG. 11Billustrates the mouthpiece in an extended operative position.

FIG. 12 illustrates the display of physiological and environmentalinformation collected by a monitoring device and displayed on a mobileoperatively coupled to the earpiece, according to some embodiments.

DETAILED DESCRIPTION

The features of the embodiments, which are believed to be novel, are setforth with particularity in the appended claims. The embodiments maybest be understood by reference to the following description, taken inconjunction with the accompanying drawings. The examples illustrated,however, may be embodied in many different forms and should not beconstrued as limited to the embodiments set forth herein; rather, theseembodiments are provided so that this disclosure will be thorough andcomplete, and will fully convey the scope of the invention to thoseskilled in the art.

While the specification concludes with the claims defining the featuresof the invention that are regarded as novel, it is believed that theembodiments may be better understood from a consideration of thefollowing description in conjunction with the drawings figures, in whichlike reference numerals are carried forward.

The terms and phrases used herein are not intended to be limiting butrather to provide an understandable description of the embodiments.

The terms “a” or “an”, as used herein, are defied as one or more thanone. The term “another”, as used herein, is defined as at least a secondor more. The terms “including” and/or “having” as used herein, aredefined as comprising (i.e. open transition). The term “coupled” or“operatively coupled” as used herein, is defined as connected, althoughnot necessarily directly, and not necessarily mechanically. It will befurther understood that the terms “comprises” and/or “comprising,” whenused in this specification, specify the presence of stated features,steps, operations, elements, and/or components, but do not preclude thepresence or addition of one or more other features, steps, operations,elements, components, and/or groups thereof. As used herein, the term“and/or” includes any and all combinations of one or more of theassociated listed items. Like numbers refer to like elements throughout.In the figures, the sizes of certain lines, layers, components, elementsor features may be exaggerated for clarity.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being “on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on”, “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “adjacent” another feature may have portions thatoverlap or underlie the adjacent feature.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of a device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of “over” and “under”. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

The term earpiece or “earpiece module” includes any type of device thatmay be attached to or near the ear of a user and may have variousconfigurations, without limitation. Such configurations include, but arenot limited to, earpieces, ear buds, headphones, headsets, hearing aids,personal sound amplification products (PSAPS), and glasses.

The term “real-time” is used to describe a process of sensing,processing, or transmitting information in a time frame which is equalto or shorter than the minimum timescale at which the information isneeded. For example, the real-time monitoring of pulse rate may resultin a single average pulse-rate measurement every minute, averaged over30 seconds, because an instantaneous pulse rate is often useless to theend user. Typically, averaged physiological and environmentalinformation is more relevant than instantaneous changes. Thus, in thecontext of the present invention, signals may sometimes be processedover several seconds, or even minutes, in order to generate a“real-time” response.

The term “monitoring” refers to the act of measuring, quantifying,qualifying, estimating, sensing, calculating, interpolating,extrapolating, inferring, deducing, or any combination of these actions.More generally, “monitoring” refers to a way of getting information viaone or more sensing elements. For example, “blood health monitoring” caninclude monitoring of blood gas levels, blood hydration, blood flow, andmetabolite/electrolyte levels. In the embodiments herein, the term“physiological” is intended to be used broadly, covering both physicaland psychological characteristics of or from the body of an organism.However, in some cases, the term “psychological” is called-outseparately to emphasize aspects of physiology that are more related tobrain activity and a state of being or mood rather than the activity ofother organs, tissues, or cells. In this regard, multimodal monitoringcan enhance the meaning or interpretation of psychological information,particularly with the analysis of voice, words, phrases and semantics inconjunction with other physiological measurements as further detailedbelow.

It should be understood that the embodiments herein can apply and beadapted to animals having vastly different anatomical structures thanhumans. For example, an earpiece attached or inserted into a cow, a dog,or a horse's ear (or other anatomical conduit) will have vastlydifferent shapes or architectures, but can certainly be adapted to formsealed chambers or conduits sufficient to provide isolation inaccordance with the embodiments. Thus, tracking or monitoring a cow'shealth, productivity or other parameters or a dog or a horse's speed orsentiment (during training) using some of the objective techniquesherein for deciphering or understanding semantics (for humans) canequally apply to animals.

The term “health” refers generally to the quality or quantity of one ormore physiological parameters with reference to an organism's functionalabilities. Health can include both private and public information. Inthe private portion, health information is personalized for each subjectthat is stored. In the public portion, anonymous health is stored and isaccessible by third parties. The private or public health informationmay also include environmental information or other data as well.

The term “ad hoc” refers generally to a wireless connection establishedfor the duration of one session without the need for a base station.Instead, devices discover others within range to form a network.Bluetooth®, Low Energy Bluetooth, Zigbee, and Wi-Fi protocols are a fewexamples. The term “processor” typically refers to logic circuitry thatresponds to and processes basic instructions that drive a computer orother electronic devices. The term processor has generally replaced theterm central processing unit (CPU) and can further refer to amicroprocessor, a digital signal processor, a programmable logic device,an application specific integrated circuit or ASIC or any number ofother logic devices. The processor in a personal computer or embedded insmall devices is often called a microprocessor. The term “sensor” refersto a device that detects or measures a physical property and enables therecording, presentation or response to such detection or measurementusing processor and optionally memory. A sensor and processor can takeone form of information and convert such information into another form,typically having more usefulness than the original form. For example, asensor may collect raw physiological or environmental data from varioussensors and process this data into a meaningful assessment, such aspulse rate, blood pressure, or air quality using a processor. A “sensor”herein can also collect or harvest acoustical data for biometricanalysis (by a processor) or for digital or analog voice communications.A “sensor” can include any one or more of a physiological sensor (e.g.,blood pressure, heart beat, etc.), a biometric sensor (e.g., a heartsignature, a fingerprint, etc.), an environmental sensor (e.g.,temperature, particles, chemistry, etc.), a neurological sensor (e.g.,brainwaves, EEG, etc.), or an acoustic sensor (e.g., sound pressurelevel, voice recognition, sound recognition, etc.) among others. Avariety of microprocessors or other processors may be used herein.Although a single processor or sensor may be represented in the figures,it should be understood that the various processing and sensingfunctions can be performed by a number of processors and sensorsoperating cooperatively or a single processor and sensor arrangementthat includes transceivers and numerous other functions as furtherdescribed herein.

The term “clinical study” refers broadly to the application of scienceto health, where “health” may refer to both physical health as well asmental or psychological health. The term “clinical study” and “clinicaltrial” are used interchangeably herein. As an example, the interactionbetween a therapy and health or physiology—such as a drug therapy,exercise/diet plan, physical regime, etc.—can constitute a clinicalstudy. As another example, the interaction between the health and theenvironmental exposure of individuals or groups can constitute aclinical study. In some cases a clinical study is performed byprofessionals in medicine or science. In other cases, a clinical studyis performed by amateurs, computer programs, or individuals themselves,sometimes in the form of self help.

The term “marketing” refers to the act of bringing together buyers andsellers, and the term “marketing study” refers to the study of the needsand wants of buyers and sellers and how the buyers and sellers can cometogether.

The term “health study” refers to monitoring the health of an organismand studying the data regardless of the method of study.

The term “wellness” generally refers to a healthy balance of themind-body and spirit that results in an overall feeling of well-being,and/or the state of being healthy. The term “wellness study” refers tothe study of the quality of health and wellbeing. In some cases awellness study is performed by professionals in medicine or science. Inother cases, a clinical study is performed by amateurs, computerprograms, or individuals themselves, sometimes in the form of self help.

The term “dieting plan” refers to a method of planning and/or regulatingthe intake of food or nutrients into the body. The term “exercise plan”refers to a method of planning or regulating physical activity. In manycases, a diet/exercise plan are used together to improve or reducehealth. These plans can be operated by professionals, such asprofessional dieticians or physical trainers, or by amateurs. In somecases, these plans are regulated by computer programs or individualsthemselves, sometimes in the form of self help.

The term “health study” refers to studying health as in its raw form,without necessarily being concerned about interactions between healthand other factors.

The term “sickness and/or disease” refers generally to aspects of asickness, disease, or injury in an individual or group of individuals.

The term “environmental exposure” refers to any environmental occurrence(or energy) to which an individual or group of individuals is exposed.For example, exposure to solar energy, air pollution, water pollution,temperature, nuclear radiation, humidity, particles, water, etc. whichmay all constitute environmental exposure. A variety of relevantenvironmental energies are listed elsewhere herein.

In many cases, the above cases overlap. As an example, a clinical studyor wellness study may explore or record the interaction betweenphysiological elements & environmental elements.

The term “aggregated” refers to information that is stored and/orgrouped. In some cases, these groupings can be based on personal ordemographical information, such as grouping based on ethnicity, sex,income, personal preferences or the like. Aggregated information,particularly in social media contexts, in addition to the personal ordemographic information can also include current or recent locationinfo, current or recent activity info, as well as current or recentbiometric, physiological, or environmental information. For example, adevice can enable the sharing of current location (e.g., at theGuggenheim Museum in NYC, or a pharmacy in Colorado), current orrecently listened to content (whether reproduced in the ear (e.g.,listening to a streaming or downloaded Andrea Bocelli album) or heardvia an ambient microphone in the field (e.g., at a Cold Play concert)and recent keywords from a conversation or exchange with a third party(e.g., “I'll have a little of the red cab” or “Bartender, can I have aSierra Nevada Pale Ale” or “Fill this prescription for Girl ScoutCookies or OG Kush for me dude”), and a current physiological measure(e.g., current heart rate or blood pressure) to create a possibly sharedpoint of interest with another individual in a social network. As can beimagined, the results can be surprising

The term “multimodal” refers to monitoring of at least two differentparameters such as sound pressure level and blood pressure or heartrate. Note, the different parameters can be related types ofmeasurements such as hear rate and blood pressure, but they can alsoquite different capture or harvested from acoustic, biologic,neurologic, motion, or vision sensors as examples. In some embodiments,multimodal monitoring can enhance the interpretation and analysisrelating to semantics. For example, the reading of motion, brainwaves,sound pressure level, blood pressure, or heart rate along with voicerecognition analysis of spoken words can provide richer contextualmeaning. Assuming baseline readings exist for an individual, multimodalreadings can more clearly determine if an elevated heart beat or bloodpressure reading is an indication of potential sleep disorder or heartdisease within the context of a typical daily activity (e.g., sleeping,walking or sitting) or within the context of a less typical dailyactivity (e.g, sprinting to catch a bus or rigorously exercising).Multimodal analysis or processing can enhance the logical interpretationgiven to words. In other words, multimodal analysis or processing canimprove a semantics engine that interprets the logic and meaning inspoken words.

The terms “health and environmental network” and “health andenvironmental monitoring system” are used interchangeably herein. Theterms “monitoring system” and “network” may be used interchangeably, aswell. The term “biofeedback” relates to measuring a subject's bodilyprocesses such as blood pressure, heart rate, skin temperature, galvanicskin response (sweating), muscle tension, etc., and conveying suchinformation to the subject in real-time in order to raise the subject'sawareness and conscious control of the related physiological activities.Herein, biofeedback is synonymous with personal physiologicalmonitoring, where biochemical processes and environmental occurrencesmay be integrated into information for one or more individuals. Forexample, monitoring hormone levels and air quality through theinnovative sensor network described herein for the purpose of tracking,predicting, and/or controlling ovulation is also considered biofeedback.Biofeedback is also considered a technique used to learn to controlbodily functions, such as heart rate. With biofeedback, the user can beconnected to electrical sensors that help the user receive information(feedback) about their body (bio). This feedback helps the user focus onmaking subtle changes in their body, such as relaxing certain muscles,to achieve the desired results, such as reducing pain. In essence,biofeedback gives the user the power to use their thoughts to controltheir body, often to help with a health condition or physicalperformance. Biofeedback is often used as a relaxation technique.

The term “profile” relates to a summary of noteworthy characteristicsand/or habits of an individual or group of individuals. Thesecharacteristics may be physiological (health-related), environmental,statistical, demographical, behavioral, and the like. Age, location,gender, sex, weight, ethnicity, and/or height may be included in aprofile. The profile and the aforementioned characteristics and/orhabits can be used in the context of social media and furtherinformation in the interactions within a social media network can beextracted to form a part of a profile as well Additionally, a profilemay reference the buying and/or spending habits of an individual orgroup and can further include a credit rating. Profiles may be utilizedin making predictions about an individual or group.

The term “support,” when used as a verb, means to assist and/or provideat least one method or outcome for something. For example, a method ofsupporting a therapy for something may refer to a method of assisting atherapeutic technique. In some cases, supporting a therapy may involveproviding an entirely new method having a therapeutic outcome. As a morespecific example, a noninvasive health and environmental monitorsystem/network may support a therapeutic drug study by noninvasivelymonitoring the real-time drug dosage in the body through multiwavelengthpulse oximetry, monitoring core body temperature through thermal sensingof the tympanic membrane, and monitoring environments which maypositively or negatively affect the quality of the drug therapy.

In the following figures, earpiece modules will be illustrated anddescribed for insertion within the ear canal of the human body. Itshould be noted that the ear canal makes for a excellent location tointerface with a multimodality biometric, environmental, neurologicaland acoustic sensor and communications array as will be furtherdescribed. However, it is to be understood that embodiments of thepresent invention are not limited to those worn by humans or even in abiological context. Moreover, monitoring apparatus according toembodiments are not limited to earpiece modules and/or devicesconfigured to be attached to or inserted within the ear. Monitoringapparatus according to embodiments herein may be worn on various partsof the body or even worn inside the body. Different monitoring unitsworking across the body can be used as a system, integrating, sharingand providing feedback to a user or care providers. The feedback can begiven to the user in many different forms including acoustically,hepatically, visually via any number of sensors including viatemperature sensors and neurological sensors to just name a few.

Some embodiments arise from a discovery that the ear canal is an ideallocation on or in the human body for a wearable health and environmentalmonitor. The ear canal is a relatively immobile platform that does notobstruct a person's movement or vision. Devices located along the earcan have access to the inner-ear canal and tympanic membrane (formeasuring core body temperature), muscle tissue (for monitoring muscletension), The ear canal is also at or near the point of exposure to:environmental breathable toxicants of interest (volatile organiccompounds, pollution, etc.); noise pollution experienced by the ear andits assorted pathway to the tympanic membrane called the ExternalAuditory Canal (EAC). Internal to the skull, this location is contains asoft tissue which is adjacent to the brain, as such the ear canal servesas an excellent location for mounting neurological and electricalsensors for monitoring brain activity. Furthermore, as the ear canal isnaturally designed for capturing or harvesting acoustical energy, theear canal provides an optimal location for monitoring internal sounds,such as heartbeat, breathing rate, and mouth motion, and one's own voicevia bone conduction. In some embodiments, other locations on the bodycan be outfitted with sensors and operate in conjunction with sensors inan ear canal. For example, some embodiments can optionally use the pinnaand earlobe (for monitoring blood gas levels), the region behind the ear(for measuring skin temperature and galvanic skin response), and theinternal carotid artery (for measuring cardiopulmonary functioning).Note that blood gas levels and skin temperature may also be measuredwithin the ear canal as well.

Providing sufficient isolation within an ear canal to mitigate outsideor environmental factors also forms a portion of the embodiments herein.The use of an inflatable element, stretched membrane or balloon that canoptionally to both mitigate external sounds as well as house or serve asa vehicle for a number of sensors enhances the stability and reliabilityof sensors for use in a number of physiological readings.

Bluetooth®-enabled and/or other personal communication earpiece modulesmay be configured to incorporate physiological and/or environmentalsensors, according to some embodiments of the present invention.Bluetooth® 3.0, 4.0, or LE or now Bluetooth® Smart are the intelligent,power-friendly versions of Bluetooth wireless technology. While thepower-efficiency of Bluetooth Smart makes it perfect for devices needingto run off a tiny battery for long periods, the Bluetooth Smart abilityto work with an application on current smartphones or tablets makes iteasy for developers and OEMs to create solutions that will work with thebillions of Bluetooth enabled products already in the market today.Existing Bluetooth® earpiece modules are considered typicallylightweight, but often very obtrusive devices that have become widelyaccepted socially. Moreover, Bluetooth® earpiece modules are costeffective, easy to use, low power and are often worn by users for a goodportion of their waking hours. Embodiments herein can take advantage ofsuch Bluetooth characteristics and enable and encourage users to weartheir devices for not only a portion of their waking hours but a vastmajority of their day or night including periods of sleep if desiredBluetooth® earpiece modules configured according to embodiments canprovide a function for the user beyond health monitoring, such aspersonal communication and multimedia applications, thereby encouraginguser compliance. Exemplary physiological and environmental sensors thatmay be incorporated into a Bluetooth® or other type of earpiece moduleinclude, but are not limited to accelerometers, auscultatory sensors,pressure sensors, humidity sensors, color sensors, light intensitysensors, pulse oximetry sensors, pressure sensors, etc. Another type ofcommunication protocol known as ZigBee can be used in the embodimentsherein to create personal area networks built from small, low-powerdigital radios. ZigBee is based on an IEEE 802.15.4 standard. Though itslow power consumption limits transmission distances to 10-100 metersline-of-sight, depending on power output and environmentalcharacteristics, ZigBee devices can transmit data over long distances bypassing data through a mesh network of intermediate devices to reachmore distant ones. ZigBee is typically used in low data rateapplications that require long battery life and secure networking(ZigBee networks are secured by 128 bit symmetric encryption keys.)ZigBee applications currently include wireless light switches,electrical meters with in-home-displays, traffic management systems, andother consumer and industrial equipment that requires short-rangelow-rate wireless data transfer. The technology defined by the ZigBeespecification is intended to be simpler and less expensive than otherwireless personal area networks (WPANs), such as Bluetooth or Wi-Fi.Thus, embodiments herein are intended to be used with or without aphone. Typical applications between a phone and a monitoring earpiecewould likely use Bluetooth while other applications that communicatebetween the earpiece and a home appliance might use ZigBee or Bluetooth.

A “phoneless” model of the monitoring device in the form of an earpiecemay incorporate any number of the functions of a phone. For example,such embodiments could include an earpiece with a GPS location device orother location or tracking device. A pipeline to the Internet or othercommunication network can be provided using any of the aforementionedcommunications protocols such as Bluetooth, WiFi, or ZigBee instead of acellular network. In some embodiments, the earpiece itself canincorporate or include a cellular phone transceiver, even if batterylife may continue to be an issue with current technologies. Withadditional improvements in phone transceiver battery drain and batterytechnologies, a longer-range communication system incorporated into anearpiece is feasible. In that regard, a WiMax communication transceiveror a Peer-to-Peer system can also be other possible alternative withinthe scope of the contemplated embodiments. In some embodiments, anearpiece can include a wired connector such as a USB or Apple Lightningconnector to enable downloads and uploads to and from the earpiece to acomputer or server or a cloud-based system via a computer network.

Wireless earpiece devices incorporating low-profile sensors and otherelectronics, according to embodiments, offer a platform for performingnear-real-time personal health and environmental monitoring in wearable,socially acceptable devices. The ability to make the earpiece nearly orcompletely imperceptible to others also furthers the socialacceptability of such embodiments and overcomes the stigmas associatedwith clearly visible devices such as glasses and hearing aids. Thecapability to unobtrusively monitor an individual's physiology and/orenvironment, combined with improved user compliance, is expected to havesignificant impact on future planned health and environmental exposurestudies. This is especially true for those that seek to linkenvironmental stressors with personal stress level indicators. The largescale commercial availability of such low-cost devices can enablecost-effective large scale studies. The combination of monitored datawith user location via GPS (Global Positioning System) and/or otherlocation data can make on-going geographic studies possible, includingthe tracking of infection over large geographic areas. The commercialapplication of the proposed platform encourages individual-driven healthmaintenance and promotes a healthier lifestyle through proper caloricintake and exercise.

Embodiments herein are not limited to devices that communicatewirelessly. In some embodiments of the present invention, devicesconfigured to monitor an individual's physiology and/or environment maybe wired to a device that stores, processes, and/or transmits data. Insome embodiments, this information may be stored on the earpiece moduleitself. In view of the above discussion, systems and methods formonitoring various physiological and environmental factors, as well assystems and methods for using this information for a plurality of usefulpurposes, are provided. According to some embodiments, real-time,noninvasive health and environmental monitors include a plurality ofcompact sensors integrated within small, low-profile devices that arefurther secured and made more environmentally isolated using aninflatable element or balloon and in some embodiments mounted within avessel, organ, body conduit, orifice, for which the biometric data canbe acquired. Physiological and environmental data can be collected oracquired and wirelessly transmitted into a wireless network, where thedata is stored and/or processed. This information is then used tosupport a variety of useful methods, such as sports training ormonitoring, clinical trials, marketing studies, biofeedback,entertainment, identity verification, authentication, purchaseauthorizations, and others. In a general sense, embodiments herein areprimarily defined in either a device or method that uses three majorpathways that include a first pathway for user interfaces andinteractions, a second pathway for sensing, and a third pathway foranalysis based on sensed data and optionally based on user interactions.Most embodiments contemplated herein include an auditory front end thatincludes at least one microphone and at least one speaker. In manyembodiments, the auditory front end can include an ambient or externalmicrophone as well as an ear canal microphone and speaker for use in anear canal known as an ear canal receiver. Embodiments can include anexpandable element or balloon as discussed above or a stressed membranethat isolates, occludes or substantially occludes one portion of aconduit from another. In the case of an ear canal, the stressed membraneor expandable element would isolate a portion of the ear canal typicallyfrom the tympanic membrane to a point within the ear canal where a wallof the expandable element radially contacts a surface of the ear canalwall. In the case of an earpiece, the expandable element can occlude anear canal or seal an ear canal volume to isolate the ear canal volumefrom an ambient environment external to the ear canal volume. Furthernote that the expandable balloon element can integrate or more sensorson, embedded within, or inside the expandable element.

In some embodiments, a system or device for insertion within an earcanal or other biological conduit or non-biological conduits comprisesat least one sensor, a mechanism for either being anchored to abiological conduit or occluding the conduit, and a vehicle forprocessing and communicating any acquired sensor data. In someembodiments, the device is a wearable device for insertion within an earcanal and comprises an expandable element or balloon used for occludingthe ear canal. The wearable device can include one or more sensors thatcan optionally include sensors on, embedded within, layered, on theexterior or inside the expandable element or balloon. Sensors can alsobe operationally coupled to the monitoring device either locally or viawireless communication. Some of the sensors can be housed in a mobiledevice or jewelry worn by the user and operationally coupled to theearpiece. In other words, a sensor mounted on phone or another devicethat can be worn or held by a user can serve as yet another sensor thatcan capture or harvest information and be used in conjunction with thesensor data captured or harvested by the earpiece monitoring device. Inyet other embodiments, a vessel, a portion of human vasculature, orother human conduit (not limited to an ear canal) can be occludedmonitored with different types of sensors. For example, a nasal passage,gastric passage, vein, artery or a bronchial tube can be occluded with aballoon or stretched membrane and monitored for certain coloration,acoustic signatures, gases, temperature, blood flow, bacteria, viruses,or pathogens (just as a few examples) using an appropriate sensor orsensors.

In some embodiments, a system or device 1 as illustrated in FIG. 1A, canbe part of an integrated miniaturized earpiece (or other body worn orembedded device) that includes all or a portion of the components shown.In other embodiments, a first portion of the components shown comprisepart of a system working with an earpiece having a remaining portionthat operates cooperatively with the first portion. In some embodiments,an fully integrated system or device 1 can include an earpiece having apower source 2 (such as button cell battery, a rechargeable battery, orother power source) and one or more processors 4 that can process anumber of acoustic channels, provide for hearing loss correction andprevention, process sensor data, convert signals to and from digital andanalog and perform appropriate filtering. In some embodiments, theprocessor 4 is formed from one or more digital signal processors (DSPs).The device can include one or more sensors 5 operationally coupled tothe processor 4. Data from the sensors can be sent to the processordirectly or wirelessly using appropriate wireless modules 6A andcommunication protocols such as Bluetooth, WiFi, NFC, RF, and Opticalsuch as infrared for example. The sensors can constitute biometric,physiological, environmental, acoustical, or neurological among otherclasses of sensors. In some embodiments, the sensors can be embedded orformed on or within an expandable element or balloon that is used toocclude the ear canal. Such sensors can include non-invasive contactlesssensors that have electrodes for EEGs, ECGs, transdermal sensors,temperature sensors, transducers, microphones, optical sensors, motionsensors or other biometric, neurological, or physiological sensors thatcan monitor brainwaves, heartbeats, breathing rates, vascularsignatures, pulse oximetry, blood flow, skin resistance, glucose levels,and temperature among many other parameters. The sensor(s) can also beenvironmental including, but not limited to, ambient microphones,temperature sensors, humidity sensors, barometric pressure sensors,radiation sensors, volatile chemical sensors, particle detectionsensors, or other chemical sensors. The sensors 5 can be directlycoupled to the processor 4 or wirelessly coupled via a wirelesscommunication system 6A. Also note that many of the components shown canbe wirelessly coupled to each other and not necessarily limited to thewireless connections shown.

As an earpiece, some embodiments are primarily driven by acousticalmeans (using an ambient microphone or an ear canal microphone forexample), but the earpiece can be a multimodal device that can becontrolled by not only voice using a speech or voice recognition engine3A (which can be local or remote), but by other user inputs such asgesture control 3B, or other user interfaces 3C can be used (e.g.,external device keypad, camera, etc). Similarly, the outputs canprimarily be acoustic, but other outputs can be provided. The gesturecontrol 3B, for example, can be a motion detector for detecting certainuser movements (finger, head, foot, jaw, etc.) or a capacitive or touchscreen sensor for detecting predetermined user patterns detected on orin close proximity to the sensor. The user interface 3C can be a cameraon a phone or a pair of virtual reality (VR) or augmented reality (AR)“glasses” or other pair of glasses for detecting a wink or blink of oneor both eyes. The user interface 3C can also include external inputdevices such as touch screens or keypads on mobile devices operativelycoupled to the device 1. The gesture control can be local to theearpiece or remote (such as on a phone). As an earpiece, the output canbe part of a user interface 8 that will vary greatly based on theapplication 9B (which will be described in further detail below). Theuser interface 8 can be primary acoustic providing for a text to speechoutput, or an auditory display, or some form of sonification thatprovides some form of non-speech audio to convey information orperceptualize data. Of course, other parts of the user interface 8 canbe visual or tactile using a screen, LEDs and/or haptic device asexamples.

In one embodiment, the User Interface 8 can use what is known as“sonification” to enable wayfinding to provide users an auditory meansof direction finding. For example and analogous to a Geiger counter, theuser interface 8 can provide a series of beeps or clicks or other soundthat increase in frequency as a user follows a correct path towards apredetermined destination. Straying away from the path will providebeeps, clicks or other sounds that will then slow down in frequency. Inone example, the wayfinding function can provide an alert and steer auser left and right with appropriate beeps or other sonification. Thesounds can vary in intensity, volume, frequency, and direction to assista user with wayfinding to a particular destination. Differences orvariations using one or two ears can also be exploited. Head-relatedtransfer function (HRTF) cues can be provided. A HRTF is a response thatcharacterizes how an ear receives a sound from a point in space; a pairof HRTFs for two ears can be used to synthesize a binaural sound thatseems to come from a particular point in space. Humans have just twoears, but can locate sounds in three dimensions in terms of range(distance), in terms of direction above and below, in front and to therear, as well as to either side. This is possible because the brain,inner ear and the external ears (pinna) work together to make inferencesabout location. This ability to localize sound sources may havedeveloped in humans and ancestors as an evolutionary necessity, sincethe eyes can only see a fraction of the world around a viewer, andvision is hampered in darkness, while the ability to localize a soundsource works in all directions, to varying accuracy, regardless of thesurrounding light. Some consumer home entertainment products designed toreproduce surround sound from stereo (two-speaker) headphones use HRTFsand similarly, such directional simulation can be used with earpieces toprovide a wayfinding function.

In some embodiments, the processor 4 is coupled (either directly orwirelessly via module 6B) to memory 7A which can be local to the device1 or remote to the device (but part of the system). The memory 7A canstore acoustic information, raw or processed sensor data, or otherinformation as desired. The memory 7A can receive the data directly fromthe processor 4 or via wireless communications 6B. In some embodiments,the data or acoustic information is recorded (7B) in a circular bufferor other storage device for later retrieval. In some embodiments, theacoustic information or other data is stored at a local or a remotedatabase 7C. In some embodiments, the acoustic information or other datais analyzed by an analysis module 7D (either with or without recording7B) and done either locally or remotely. The output of the analysismodule can be stored at the database 7C or provided as an output to theuser or other interested part (e.g., user's physician, a third partypayment processor. Note that storage of information can vary greatlybased on the particular type of information obtained. In the case ofacoustic information, such information can be stored in a circularbuffer, while biometric and other data may be stored in a different formof memory (either local or remote). In some embodiments, captured orharvested data can be sent to remote storage such as storage in “thecloud” when battery and other conditions are optimum (such as duringsleep).

In some embodiments, the earpiece or monitoring device can be used invarious commercial scenarios. One or more of the sensors used in themonitoring device can be used to create a unique or highlynon-duplicative signature sufficient for authentication, verification oridentification. Some human biometric signatures can be quite unique andbe used by themselves or in conjunction with other techniques tocorroborate certain information. For example, a heart beat or heartsignature can be used for biometric verification. An individual's heartsignature under certain contexts (under certain stimuli as whenlistening to a certain tone while standing or sitting) may have certaincharacteristics that are considered sufficiently unique. The heartsignature can also be used in conjunction with other verificationschemes such as pin numbers, predetermined gestures, fingerprints, orvoice recognition to provide a more robust, verifiable and securesystem. In some embodiments, biometric information can be used toreadily distinguish one or more speakers from a group of known speakerssuch as in a teleconference call or a videoconference call.

In some embodiments, the earpiece can be part of a payment system 9Athat works in conjunction with the one or more sensors 5. In someembodiments, the payment system 9A can operate cooperatively with awireless communication system 6B such as a 1-3 meter Near FieldCommunication (NFC) system, Bluetooth wireless system, WiFi system, orcellular system. In one embodiment, a very short range wireless systemuses an NFC signal to confirm possession of the device in conjunctionwith other sensor information that can provide corroboration ofidentification, authorization, or authentication of the user for atransaction. In some embodiments, the system will not fully operateusing an NFC system due to distance limitations and therefore anotherwireless communication protocol can be used.

In one embodiment, the sensor 5 can include a Snapdragon Sense ID 3Dfingerprint technology by Qualcomm or other designed to boost personalsecurity, usability and integration over touch-based fingerprinttechnologies. The new authentication platform can utilize Qualcomm'sSecureMSM technology and the FIDO (Fast Identity Online) AllianceUniversal Authentication Framework (UAF) specification to remove theneed for passwords or to remember multiple account usernames andpasswords. As a result, in the future, users will be able to login toany website which supports FIDO through using their device and apartnering browser plug-in which can be stored in memory 7A orelsewhere. solution) The Qualcomm fingerprint scanner technology is ableto penetrate different levels of skin, detecting 3D details includingridges and sweat pores, which is an element touch-based biometrics donot possess. Of course, in a multimodal embodiment, other sensor datacan be used to corroborate identification, authorization orauthentication and gesture control can further be used to provide alevel of identification, authorization or authentication. Of course, inmany instances, 3D fingerprint technology may be burdensome andconsidered “over-engineering” where a simple acoustic or biometric pointof entry is adequate and more than sufficient. For example, after aninitial login, subsequent logins can merely use voice recognition as ameans of accessing a device. If further security and verification isdesired for a commercial transaction for example, then other sensors asthe 3D fingerprint technology can be used.

In some embodiments, an external portion of the earpiece (e.g., an endcap) can include a fingerprint sensor and/or gesture control sensor todetect a fingerprint and/or gesture. Other sensors and analysis cancorrelate other parameters to confirm that user fits a predetermined orhistorical profile within a predetermined threshold. For example, aresting heart rate can typically be within a given range for a givenamount of detected motion. In another example, a predetermined brainwavepattern in reaction to a predetermined stimulus (e.g., music, soundpattern, visual presentation, tactile stimulation, etc.) can also befound be within a given range for a particular person. In yet anotherexample, sound pressure levels (SPL) of a user's voice and/or of anambient sound can be measured in particular contexts (e.g, in aparticular store or at a particular venue as determined by GPS or abeacon signal) to verify and corroborate additional information allegedby the user. For example, a person conducting a transaction at a knownvenue having a particular background noise characteristic (e.g.,periodic tones or announcements or Muzak playing in the background atknown SPL levels measured from a point of sale) commonly frequented bythe user of the monitoring device can provide added confirmation that aparticular transaction is occurring in a location by the user. Inanother context, if a registered user at home (with minimal backgroundnoise) is conducting a transaction and speaking with a customer servicerepresentative regarding the transaction, the user may typically speakat a particular volume or SPL indicative that the registered user is theactual person claiming to make the transaction. A multimodal profile canbe built and stored for an individual to sufficiently corroborate orcorrelate the information to that individual. Presumably, thecorrelation and accuracy becomes stronger over time as more sensor datais obtained as the user utilizes the device 1 and a historical profileis essentially built. Thus, a very robust payment system 9A can beimplemented that can allow for mobile commerce with the use of theearpiece alone or in conjunction with a mobile device such as a cellularphone. Of course, information can be stored or retained remotely inserver or database and work cooperatively with the device 1. In otherapplications, the pay system can operate with almost any type ofcommerce.

Referring to FIG. 1B, a device 1, substantially similar to the device 1of FIG. 1A is shown with further details in some respects and lessdetails in other respects. For simplicity, local or remote memory, localor remote databases, and features for recording can all be representedby the storage device 7 which can be coupled to an analysis module 7D.As before, the device can be powered by a power source 2. The device 1can include one or more processors 4 that can process a number ofacoustic channels and process such channels for situational awarenessand/or for keyword or sound pattern recognition, as well as daily speechthe user speaks, coughs, sneezes, etc. The processor(s) 4 can providefor hearing loss correction and prevention, process sensor data, convertsignals to and from digital and analog and perform appropriate filteringas needed. In some embodiments, the processor 4 is formed from one ormore digital signal processors (DSPs). The device can include one ormore sensors 5 operationally coupled to the processor 4. The sensors canbe biometric and/or environmental. Such environmental sensors can senseone or more among light, radioactivity, electromagnetism, chemicals,odors, or particles. The sensors can also detect physiological changesor metabolic changes. In some embodiments, the sensors can includeelectrodes or contactless sensors and provide for neurological readingsincluding brainwaves. The sensors can also include transducers ormicrophones for sensing acoustic information. Other sensors can detectmotion and can include one or more of a GPS device, an accelerometer, agyroscope, a beacon sensor, or NFC device. One or more sensors can beused to sense emotional aspects such as stress or other affectiveattributes. In a multimodal, multisensory embodiment, a combination ofsensors can be used to make emotional or mental state assessments orother anticipatory determinations.

User interfaces can be used alone or in combination with theaforementioned sensors to also more accurately make emotional or mentalstate assessments or other anticipatory determinations. A voice controlmodule 3A can include one or more of an ambient microphone, an ear canalmicrophone or other external microphones (e.g., from a phone, lap top,or other external source) to control the functionality of the device 1to provide a myriad of control functions such as retrieving searchresults (e.g., for information, directions) or to conduct transactions(e.g., ordering, confirming an order, making a purchase, canceling apurchase, etc.), or to activate other functions either locally orremotely (e.g., turn on a light, open a garage door). The use of anexpandable element or balloon for sealing an ear canal can bestrategically used in conjunction with an ear canal microphone (in thesealed ear canal volume) to isolate a user's voice attributable to boneconduction and correlate such voice from bone conduction with the user'svoice picked up by an ambient microphone. Through appropriate mixing ofthe signal from the ear canal microphone and the ambient microphone,such mixing technique can provide for a more intelligible voicesubstantially free of ambient noise that is more recognizable by voicerecognition engines such as SIRI by Apple, Google Now by Google, orCortana by Microsoft.

The voice control interface 3A can be used alone or optionally withother interfaces that provide for gesture control 3B. Alternatively, thegesture control interface(s) 3B can be used by themselves. The gesturecontrol interface(s) 3B can be local or remote and can be embodied inmany different forms or technologies. For example, a gesture controlinterface can use radio frequency, acoustic, optical, capacitive, orultrasonic sensing. The gesture control interface can also beswitch-based using a foot switch or toe switch. An optical or camerasensor or other sensor can also allow for control based on winks,blinks, eye movement tracking, mandibular movement, swallowing, or asuck-blow reflex as examples.

The processor 4 can also interface with various devices or controlmechanisms within the ecosystem of the device 1. For example, the devicecan include various valves that control the flow of fluids or acousticsound waves. More specifically, in one example the device 1 can includea shutter or “aural iris” in the form of an electro active polymer thatcontrols a level or an opening size that controls the amount of acousticsound that passes through to the user's ear canal. In another example,the processor 4 can control a level of battery charging to optimizecharging time or optimize battery life in consideration of other factorssuch as temperature or safety in view of the rechargeable batterytechnology used.

A brain control interface (BCI) 5B can be incorporated in theembodiments to allow for control of local or remote functions including,but not limited to prosthetic devices. In some embodiments, electrodesor contactless sensors in the balloon of an earpiece can pickupbrainwaves or perform an EEG reading that can be used to control thefunctionality of the earpiece itself or the functionality of externaldevices. The BCI 5B can operate cooperatively with other user interfaces(8A or 3C) to provide a user with adequate control and feedback. In someembodiments, the earpiece and electrodes or contactless sensors can beused in Evoked Potential Tests. Evoked potential tests measure thebrain's response to stimuli that are delivered through sight, hearing,or touch. These sensory stimuli evoke minute electrical potentials thattravel along nerves to the brain, and can be recorded typically withpatch-like sensors (electrodes) that are attached to the scalp and skinover various peripheral sensory nerves, but in these embodiments, thecontactless sensors in the earpiece can be used instead. The signalsobtained by the contactless sensors are transmitted to a computer, wherethey are typically amplified, averaged, and displayed. There are 3 majortypes of evoked potential tests including: 1) Visual evoked potentials,which are produced by exposing the eye to a reversible checkerboardpattern or strobe light flash, help to detect vision impairment causedby optic nerve damage, particularly from multiple sclerosis; 2)Brainstem auditory evoked potentials, generated by delivering clicks tothe ear, which are used to identify the source of hearing loss and helpto differentiate between damage to the acoustic nerve and damage toauditory pathways within the brainstem; and 3) Somatosensory evokedpotentials, produced by electrically stimulating a peripheral sensorynerve or a nerve responsible for sensation in an area of the body whichcan be used to diagnose peripheral nerve damage and locate brain andspinal cord lesions The purpose of the Evoked Potential Tests includeassessing the function of the nervous system, aiding in the diagnosis ofnervous system lesions and abnormalities, monitoring the progression ortreatment of degenerative nerve diseases such as multiple sclerosis,monitoring brain activity and nerve signals during brain or spinesurgery, or in patients who are under general anesthesia, and assessingbrain function in a patient who is in a coma. In some embodiments,particular brainwave measurements (whether resulting from EvokedPotential stimuli or not) can be correlated to particular thoughts andselections to train a user to eventually consciously make selectionsmerely by using brainwaves. For example, if a user is given a selectionamong A. Apple B. Banana and C. Cherry, a correlation of brainwavepatterns and a particular selection can be developed or profiled andthen subsequently used in the future to determine and match when aparticular user merely thinks of a particular selection such as “C.Cherry”. The more distinctively a particular pattern correlates to aparticular selection, the more reliable the use of this technique as auser input.

User interface 8A can include one or more among an acoustic output or an“auditory display”, a visual display, a sonification output, or atactile output (thermal, haptic, liquid leak, electric shock, air puff,etc.). In some embodiments, the user interface 8A can use anelectroactive polymer (EAP) to provide feedback to a user. As notedabove, a BCI 5B can provide information to a user interface 8A in anumber of forms. In some embodiments, balloon pressure oscillations orother adjustments can also be used as a means of providing feedback to auser. Also note that mandibular movements (chewing, swallowing, yawning,etc.) can alter balloon pressure levels (of a balloon in an ear canal)and be used as way to control functions. (Also note that balloonpressure can be monitored to correlate with mandibular movements andthus be used as a sensor for monitoring such actions as chewingswallowing and yawning).

Other user interfaces 3C can provide external device inputs that can beprocessed by the processor(s) 4. As noted above, these inputs include,but are not limited to, external device keypads, keyboards, cameras,touch screens, mice, and microphones to name a few.

The user interfaces, types of control, and/or sensors may likely dependon the type of application 9B. In a mobile application, a mobile phonemicrophone(s), keypad, touchscreen, camera, or GPS or motion sensor canbe utilized to provide a number of the contemplated functions. In avehicular environment, a number of the functions can be coordinated witha car dash and stereo system and data available from a vehicle. In anexercise, medical, or health context, a number of sensors can monitorone or more among, heart beat, blood flow, blood oxygenation, pulseoximetry, temperature, glucose, sweat, electrolytes, lactate, pH,brainwave, EEG, ECG or other physiological, or biometric data. Biometricdata can also be used to confirm a patient's identity in a hospital orother medical facility to reduce or avoid medical record errors andmix-ups. In a social networking environment, users in a social networkcan detect each other's presence, interests, and vital statistics tospur on athletic competition, commerce or other social goals ormotivations. In a military or professional context, various sensors andcontrols disclosed herein can offer a discrete and nearly invisible orimperceptible way of monitoring and communicating that can extend the“eyes and ears” of an organization to each individual using an earpieceas described above. In a commercial context, a short-range communicationtechnology such as NFC or beacons can be used with other biometric orgesture information to provide for a more robust and secure commercialtransactional system. In a call center context or other professionalcontext, the earpiece could incorporate a biosensor that measuresemotional excitement by measuring physiological responses. Thephysiological responses can include skin conductance or Galvanic SkinResponse, temperature and motion.

In yet other aspects, some embodiments can monitor a person's sleepquality, mood, or assess and provide a more robust anticipatory deviceusing a semantics acoustic engine with other sensors. The semanticengine can be part of the processor 4 or part of the analysis module 7Dthat can be performed locally at the device 1 or remotely as part of anoverall system. If done remotely at a remote server, the system 1 caninclude a server (or cloud) that includes algorithms for analysis ofgathered sensor data and profile information for a particular user. Incontrast to other schemes, the embodiments herein can perform semanticanalysis based on all biometrics, audio, and metadata (speaker ID, etc.)in combination and also in a much “cleaner” environments within a sealedEAC sealed by a proprietary balloon that is immune to many of thedetriments in other schemes used to attempt to seal an EAC. Depending onthe resources available at a particular time such as processing power,semantic analysis applications, or battery life, the semantic analysiswould be best performed locally within a monitoring earpiece deviceitself, or within a cellular phone operationally coupled to theearpiece, or within a remote server or cloud or a combination thereof.

Though the methods herein may apply broadly to a variety of form factorsfor a monitoring apparatus, in some embodiments herein a 2-waycommunication device in the form of an earpiece with at least a portionbeing housed in an ear canal can function as a physiological monitor, anenvironmental monitor, and a wireless personal communicator. Because theear region is located next to a variety of “hot spots” for physiologicalan environmental sensing—including the carotid artery, the paranasalsinus, etc.—in some cases an earpiece monitor takes preference overother form factors. Furthermore, the earpiece can use the ear canalmicrophone to obtain heart rate, heart rate signature, blood pressureand other biometric information such as acoustic signatures from chewingor swallowing or from breathing or breathing patterns. The earpiece cantake advantage of commercially available open-architecture, ad hoc,wireless paradigms, such as Bluetooth®, Wi-Fi, or ZigBee. In someembodiments, a small, compact earpiece contains at least one microphoneand one speaker, and is configured to transmit information wirelessly toa recording device such as, for example, a cell phone, a personaldigital assistant (PDA), and/or a computer. In another embodiment, theearpiece contains a plurality of sensors for monitoring personal healthand environmental exposure. Health and environmental information, sensedby the sensors is transmitted wirelessly, in real-time, to a recordingdevice or media, capable of processing and organizing the data intomeaningful displays, such as charts. In some embodiments, an earpieceuser can monitor health and environmental exposure data in real-time,and may also access records of collected data throughout the day, week,month, etc., by observing charts and data through an audio-visualdisplay. Note that the embodiments are not limited to an earpiece andcan include other body worn or insertable or implantable devices as wellas devices that can be used outside of a biological context (e.g., anoil pipeline, gas pipeline, conduits used in vehicles, or water or otherchemical plumbing or conduits). Other body worn devices contemplatedherein can incorporate such sensors and include, but are not limited to,glasses, jewelry, watches, anklets, bracelets, contact lenses,headphones, earphones, earbuds, canal phones, hats, caps, shoes,mouthpieces, or nose plugs to name a few. In addition, all types of bodyinsertable devices are contemplated as well.

Further note that the shape of the balloon will vary based on theapplication. Some of the various embodiments herein stem fromcharacteristics of the unique balloon geometry “UBG” sometimes referredto as stretched or flexible membranes, established from anthropomorphicstudies of various biological lumens such as the external auditory canal(EAC) and further based on the “to be worn location” within the earcanal. Other embodiments herein additionally stem from the materialsused in the construction of the UBG balloon, the techniques ofmanufacturing the UBG and the materials used for the filling of the UBG.Some embodiments exhibit an overall shape of the UBG as a prolatespheroid in geometry, easily identified by its polar axis being greaterthan the equatorial diameter. In other embodiments, the shape can beconsidered an oval or ellipsoid. Of course, other biological lumens andconduits will ideally use other shapes to perform the various functionsdescribed herein. See Provisional Patent Application No. 62/090,136entitled “MEMBRANE AND BALLOON SYSTEMS AND DESIGNS FOR CONDUITS” filedon Dec. 10, 2014, incorporated herein by reference in its entirety.

Each physiological sensor can be configured to detect and/or measure oneor more of the following types of physiological information: heart rate,pulse rate, breathing rate, blood flow, heartbeat signatures,cardio-pulmonary health, organ health, metabolism, electrolyte typeand/or concentration, physical activity, caloric intake, caloricmetabolism, blood metabolite levels or ratios, blood pH level, physicaland/or psychological stress levels and/or stress level indicators, drugdosage and/or dosimetry, physiological drug reactions, drug chemistry,biochemistry, position and/or balance, body strain, neurologicalfunctioning, brain activity, brain waves, blood pressure, cranialpressure, hydration level, auscultatory information, auscultatorysignals associated with pregnancy, physiological response to infection,skin and/or core body temperature, eye muscle movement, blood volume,inhaled and/or exhaled breath volume, physical exertion, exhaled breath,snoring, physical and/or chemical composition, the presence and/oridentity and/or concentration of viruses and/or bacteria, foreign matterin the body, internal toxins, heavy metals in the body, blood alcohollevels, anxiety, fertility, ovulation, sex hormones, psychological mood,sleep patterns, hunger and/or thirst, hormone type and/or concentration,cholesterol, lipids, blood panel, bone density, organ and/or bodyweight, reflex response, sexual arousal, mental and/or physicalalertness, sleepiness, auscultatory information, response to externalstimuli, swallowing volume, swallowing rate, mandibular movement,mandibular pressure, chewing, sickness, voice characteristics, voicetone, voice pitch, voice volume, vital signs, head tilt, allergicreactions, inflammation response, auto-immune response, mutagenicresponse, DNA, proteins, protein levels in the blood, water content ofthe blood, blood cell count, blood cell density, pheromones, internalbody sounds, digestive system functioning, cellular regenerationresponse, healing response, stem cell regeneration response, and/orother physiological information.

Each environmental sensor is configured to detect and/or measure one ormore of the following types of environmental information: climate,humidity, temperature, pressure, barometric pressure, soot density,airborne particle density, airborne particle size, airborne particleshape, airborne particle identity, volatile organic chemicals (VOCs),hydrocarbons, polycyclic aromatic hydrocarbons (PAHs), carcinogens,toxins, electromagnetic energy, optical radiation, cosmic rays, X-rays,gamma rays, microwave radiation, terahertz radiation, ultravioletradiation, infrared radiation, radio waves, atomic energy alphaparticles, atomic energy beta-particles, gravity, light intensity, lightfrequency, light flicker, light phase, ozone, carbon monoxide, carbondioxide, nitrous oxide, sulfides, airborne pollution, foreign materialin the air, viruses, bacteria, signatures from chemical weapons, wind,air turbulence, sound and/or acoustical energy, ultrasonic energy, noisepollution, human voices, human brainwaves, animal sounds, diseasesexpelled from others, exhaled breath and/or breath constituents ofothers, toxins from others, pheromones from others, industrial and/ortransportation sounds, allergens, animal hair, pollen, exhaust fromengines, vapors and/or fumes, fuel, signatures for mineral depositsand/or oil deposits, snow, rain, thermal energy, hot surfaces, hotgases, solar energy, hail, ice, vibrations, traffic, the number ofpeople in a vicinity of the person, coughing and/or sneezing sounds frompeople in the vicinity of the person, loudness and/or pitch from thosespeaking in the vicinity of the person, and/or other environmentalinformation, as well as location in, speaker identity of currentspeaker, how many individual speakers in a group, the identity of allthe speakers in the group, semantic analysis of the wearer as well asthe other speakers, and speaker ID. Essentially, the sensors herein canbe designed to detect a signature or levels or values (whether of sound,chemical, light, particle, electrical, motion, or otherwise) as can beimagined.

In some embodiments, the physiological and/or environmental sensors canbe used as part of an identification, authentication, and/or paymentsystem or method. The data gathered from the sensors can be used toidentify an individual among an existing group of known or registeredindividuals. In some embodiments, the data can be used to authenticatean individual for additional functions such as granting additionalaccess to information or enabling transactions or payments from anexisting account associated with the individual or authorized for use bythe individual.

In some embodiments, the signal processor is configured to processsignals produced by the physiological and environmental sensors intosignals that can be heard and/or viewed or otherwise sensed andunderstood by the person wearing the apparatus. In some embodiments, thesignal processor is configured to selectively extract environmentaleffects from signals produced by a physiological sensor and/orselectively extract physiological effects from signals produced by anenvironmental sensor. In some embodiments, the physiological andenvironmental sensors produce signals that can be sensed by the personwearing the apparatus by providing a sensory touch signal (e.g.,Braille, electric shock, or other).

A monitoring system, according to some embodiments of the presentinvention, may be configured to detect damage or potential damage levels(or metric outside a normal or expected reading) to a portion of thebody of the person wearing the apparatus, and may be configured to alertthe person when such damage or deviation from a norm is detected. Forexample, when a person is exposed to sound above a certain level thatmay be potentially damaging, the person is notified by the apparatus tomove away from the noise source. As another example, the person may bealerted upon damage to the tympanic membrane due to loud external noisesor other NIHL toxins. As yet another example, an erratic heart rate or acardiac signature indicative of a potential issue (e.g., heart murmur)can also provide a user an alert. A hear murmur or other potential issuemay not surface unless the user is placed under stress. As themonitoring unit is “ear-borne”, opportunities to exercise and experiencestress is rather broad and flexible. When cardiac signature is monitoredusing the embodiments herein, the signatures of potential issues (suchas heart murmur) when placed under certain stress level can becomeapparent sufficient to indicate further probing by a health carepractitioner.

Information from the health and environmental monitoring system may beused to support a clinical trial and/or study, marketing study, dietingplan, health study, wellness plan and/or study, sickness and/or diseasestudy, environmental exposure study, weather study, traffic study,behavioral and/or psychosocial study, genetic study, a health and/orwellness advisory, and an environmental advisory. The monitoring systemmay be used to support interpersonal relationships between individualsor groups of individuals. The monitoring system may be used to supporttargeted advertisements, links, searches or the like through traditionalmedia, the internet, or other communication networks. The monitoringsystem may be integrated into a form of entertainment, such as healthand wellness competitions, sports, or games based on health and/orenvironmental information associated with a user.

According to some embodiments of the present invention, a method ofmonitoring the health of one or more subjects includes receivingphysiological and/or environmental information from each subject viarespective portable monitoring devices associated with each subject, andanalyzing the received information to identify and/or predict one ormore health and/or environmental issues associated with the subjects.Each monitoring device has at least one physiological sensor and/orenvironmental sensor. Each physiological sensor is configured to detectand/or measure one or more physiological factors from the subject insitu and each environmental sensor is configured to detect and/ormeasure environmental conditions in a vicinity of the subject. Theinflatable element or balloon can provide some or substantial isolationbetween ambient environmental conditions and conditions used to measurephysiological information in a biological organism.

The physiological information and/or environmental information may beanalyzed locally via the monitoring device or may be transmitted to alocation geographically remote from the subject for analysis. Preanalysis can occur on the device or smartphone connected to the deviceeither wired or wirelessly. The collected information may undergovirtually any type of analysis. In some embodiments, the receivedinformation may be analyzed to identify and/or predict the aging rate ofthe subjects, to identify and/or predict environmental changes in thevicinity of the subjects, and to identify and/or predict psychologicaland/or physiological stress for the subjects.

According to some embodiments of the present invention, correctiveaction information may be communicated to the subjects in response toidentifying one or more health and/or environmental problems associatedwith the subject. In addition or alternatively, corrective actioninformation for the subjects may be communicated to third parties.

In some embodiments, a geographical map illustrating health-relatedand/or environmental conditions associated with the subjects may becreated.

According to some embodiments of the present invention, a health andenvironmental monitoring system includes a plurality of portablemonitoring devices, each comprising at least one physiological sensorand/or environmental sensor, a plurality of portable communicationdevices, wherein each communication device is in communication with arespective monitoring device and is configured to transmit data from themonitoring device to remote data storage, and a processor configured toanalyze data within the remote data storage and to identify and/orpredict health and/or environmental issues associated with each subject.Again, the analysis could be on accomplished on the device, sharedbetween device and computer system or all in the cloud. Eachphysiological sensor is configured to detect and/or measure or one ormore physiological data point from a respective subject, and eachenvironmental sensor is configured to detect and/or measure one or moreenvironmental conditions in a vicinity of the respective subject. Eachmonitoring device is configured to be worn by a respective subject(e.g., attached to a body of a respective subject, etc.). For example, amonitoring device may be configured to housed in an ear canal of arespective subject. In some embodiments, the full device is placedwithin an ear canal of a subject. Alternatively the concha bowl mayserve to house a location for the battery, electronics and sensors byitself or in combination with a balloon, which is located in the canal.The balloon can incorporate additional sensors in some embodiments. Insome embodiments, the device is placed in a nasal cavity, a digestiveconduit, a reproductive conduit, a kidney, a liver, a lung, a brain, abronchial conduit, an artery, a vein, a heart, or any other biologicalorgan or conduit.

In some embodiments, the processor is configured to communicatecorrective action information to each respective subject. Correctiveaction information may be communicated to each subject via themonitoring device associated with each respective subject, or via othermethods.

In other embodiments, the processor communicates corrective actioninformation for a subject to a third party. The processor may beconfigured to perform various analyses including, but not limited to,identifying and/or predicting the aging rate of one or more subjects,identifying and/or predicting environmental changes in the vicinity ofone or more subjects, and identifying and/or predicting psychologicaland/or physiological stress for one or more subjects. In someembodiments of the present invention, the processor is configured tocreate a geographical map illustrating health and/or environmentaland/or acoustic conditions associated with one or more subjects.

Information collected from each monitoring device may includeinformation that is personal and private and information that can bemade available to the public. As such, data storage, according to someembodiments of the present invention, may include a private portion anda public portion. In the private portion, health, environmental, andacoustical data that is personalized for each subject is stored. In thepublic portion, anonymous health and environmental data is stored and isaccessible by third parties.

In other embodiments, a method of delivering targeted advertising to aperson includes collecting physiological, acoustic, words, and/orenvironmental information from the person, selecting an advertisementfor delivery to the person based upon the collected physiological and/orenvironmental information, and delivering the selected advertisement tothe person. The physiological and/or environmental information iscollected via a monitoring device associated with the person and thatincludes at least one physiological sensor and/or environmental sensor,as described above. The received physiological and/or environmental,acoustic or neurological information is analyzed to identify aphysiological condition, health, level of safety of the person and/orenvironmental condition in a vicinity of the person, and anadvertisement is selected for a product or service related to anidentified physiological and/or environmental condition. The selectedfeedback, recommendations or advertisement can be delivered via any ofvarious channels including, but not limited to, short messaging service(SMS), video, graphic, acoustic, hepatic, text, email, (whether on asmartphone, computer, VR glass, body worn device, or otherwise) orpostal mail, television, radio, newspaper, magazine, the interne, andoutdoor advertising.

In some embodiments, “anticipatory services” based on the acquiredinformation can be based on monitoring a user and user interactions fora previous predetermined period of time. The monitored or acquiredinformation can be customized and for example can be set for monitoringthe past 60 seconds, that past hour(s)or the past month(s). It could bebased on trends or frequency (repetitiveness) of data such as detectingthe saying of “I love you” to your significant other.

According to some embodiments of the present invention, a method ofsupporting interpersonal relationships includes collecting physiologicaland/or environmental, or neurological information from a monitoringdevice associated with a first person when the first person is in thepresence of a second person, determining an emotional characteristiclevel such as a stress (or joy, calm, relaxation, concentration,excitation, sadness, etc.) level of the first person using the collectedphysiological and/or environmental information, and displaying thestress level to the first person (the wearer or user) or to the secondperson or a third party. The monitoring device includes at least onephysiological sensor and/or environmental sensor, as described above,and is configured to collect physiological and/or environmentalinformation that includes indicators associated with certain emotionalcharacteristic levels experienced by the first person. The stress levelof the first person may also be communicated to one or more thirdparties.

In some embodiments, a method, system and device for supportinginterpersonal relationships can include an earpiece that uses ashort-range communication system such as Near Field Communication (NFC),Bluetooth, or WiFi signals to initiate or facilitate communication amongpotential partners based on any number of various parameters. Theparameters can be selected among any one or more among pre-existingprofiles, biometric or physiological data (current, near current, orhistorical data), or environmental data. The communication can beinitiated based on a match reflecting common interests or a relativematch based on meeting certain thresholds of certain data parameters.For example, a sudden elevated heartbeat, blood pressure, or certainbrainwave activity may be used as a trigger for initiatingcommunication. Alternatively, the match can enable the user of theearpiece and the corresponding partner of interest to affirmativelyenable communication between the parties in response to a notice of suchmatch rather than having the communication being automatic. The feedbackcould include various methods and information including acousticwayfinding information, which could enable two individuals previouslyunknown to each other to meet, based on a common interest, or other datapoints as described herein.

In some embodiments, the physiological and/or environmental information,acoustical, or neurological information collected from the first personis analyzed to identify a source of stress. A solution for reducingstress also may be recommended to the first person. In some embodiments,the monitoring device can identify the second person.

According to some embodiments of the present invention, a system forsupporting interpersonal relationships includes a portable monitoringdevice that collects physiological and/or environmental, acoustical, orneurological information from a first person when the first person is inthe presence of a second person, and a processor that receivesphysiological and/or environmental, acoustical, or neurologicalinformation from the monitoring device. The processor determines astress level of the first person using the collected physiologicaland/or environmental information, and transmits and/or displays thestress level to the first person. In some embodiments, the processorreceives physiological and/or environmental information from themonitoring device via a communication device (e.g., PDA, cell phone,laptop computer, etc.) associated with the monitoring device. Theprocessor may be configured to analyze the information and identify asource of emotional characteristic level (such as stress) indicative ofa quality of life measurement. The processor may be configured torecommend solutions for reducing or increasing a particular emotionalcharacteristic level (such as stress or joy, respectively).

In another embodiment of the present invention, a method of supportinginterpersonal relationships includes collecting physiological and/orenvironmental information from a monitoring device associated with afirst person, and determining a mood of the first person using thecollected physiological and/or environmental information. The collectedinformation includes indicators associated with one or more moods of thefirst person. The mood of the first person may be communicated to asecond person, for example, via a communication network (e.g., textmessage, email, voice message, etc.). Semantic information can also beanalyzed in the context of the determined mood of the individual.

A system for supporting interpersonal relationships, according to otherembodiments of the present invention, includes a portable monitoringdevice that collects physiological and/or environmental information froma first person, and a processor that receives physiological and/orenvironmental information from the monitoring device, and determines amood of the first person using the collected physiological and/orenvironmental information. The processor receives physiological and/orenvironmental information from the monitoring device via a communicationdevice (e.g., PDA, cell phone, laptop computer, computerized glasses,etc.) associated with the monitoring device. The processor is configuredto communicate the mood of the first person to a second person, forexample, via a communication network (e.g., text message, email, voicemessage, etc.). The mood of the speaker can be evaluated from the voice,for example, but other parameters can be monitored to make suchevaluation of mood.

According to further embodiments of the present invention, a method ofmonitoring one or more subjects includes collecting physiological and/orenvironmental information from a monitoring device associated with eachrespective subject, storing the collected physiological and/orenvironmental information at a remote storage device, and comparing thestored physiological and/or environmental information with benchmarkphysiological and/or environmental information to identify at least onebehavioral response of the one or more subjects. Behavioral responsesmay include, but are not limited to, behavioral responses to a productand/or service, behavioral responses to product and/or servicemarketing, behavioral responses to medical treatment, behavioralresponses to a drug, etc.

According to some embodiments of the present invention, a system formonitoring one or more subjects includes a plurality of portablemonitoring devices configured to collect physiological information froma subject and environmental condition information in a vicinity of asubject, as described above, and a processor that compares collectedphysiological and/or environmental information with benchmarkphysiological and/or environmental information to identify at least onebehavioral response of the one or more subjects. As described above,behavioral responses may include, but are not limited to, behavioralresponses to a product and/or service, behavioral responses to productand/or service marketing, behavioral responses to medical treatment,behavioral responses to a drug, behavior responses to environmentalfactors, etc. In some embodiments, a monitoring device may include adosimeter configured to measure a dose of a drug taken by a respectivesubject.

According to further embodiments of the present invention, a method ofmonitoring patients, includes collecting physiological and/orenvironmental information from each patient via a monitoring deviceassociated with each respective patient, and analyzing the collectedinformation to determine caloric intake, health, and physical activityof each patient.

According to further embodiments of the present invention, anentertainment system includes a gaming device, and a plurality ofportable, monitoring devices in communication with the gaming device,wherein each monitoring apparatus is associated with a game participantand is configured to transmit participant physiological informationand/or environmental information wirelessly to the gaming device. Thegaming device is configured to integrate into the gaming strategyphysiological information and/or environmental information received fromeach monitoring apparatus. Each monitoring apparatus includes at leastone physiological sensor and/or environmental sensor, as describedabove. Further note that the embodiments can include toys as part of anecosystem that operates with an earpiece.

According to further embodiments of the present invention, a method ofinteracting with an electronic game includes collecting physiologicaland/or environmental information from a monitoring device associatedwith a person, analyzing the collected information to identify one ormore health and/or environmental issues associated with the person,sending the identified one or more health and/or environmental issues toa gaming device, and incorporating the identified one or more healthand/or environmental issues into a strategy of a game executing on thegaming device. The monitoring device includes at least one physiologicalsensor and/or environmental sensor, as described above.

The block diagrams of FIGS. 1A, 1B, and the earpieces of FIGS. 2A-2J inthe form of a wearable monitoring device 20, illustrate embodimentsaccording to some embodiments herein. The wearable monitoring device 20is shown in FIGS. 2A-J in various angles to emphasize various externalfeatures. FIG. 2A illustrates a left front perspective, FIG. 2Billustrates a left rear perspective, and FIG. 2C illustrates a rear planview. FIG. 2D illustrates a right front perspective, FIG. 2E illustratesanother left front perspective, and FIG. 2F illustrates a front planview with the balloon 21 facing out towards the page. FIGS. 2G and 2Hillustrate two different top perspective views. FIG. 2I illustrates aleft side view and FIG. 2J represents a right side view. In each figure,note that the balloon 21 is rotated about 20% off-center in comparisonto the main housing 23 or flange 24. Further note that theballoon/stretched membrane 21 is ovular or having an ellipsoid shape.The angle of rotation as measured from the vertical axis of the orifice,and shape are purposely made to enable the balloon 21 to guide thedevice easily into the canal and lock into place within the external earcanal (EAC) of the user. The anatomy of the human EAC has two naturalbends and lends to the rotational insertion of a balloon with theaforementioned form factor and off-center rotation. The device 20including the balloon can be short enough to be suitably be placedwithin the first bend of the EAC. Again, reference should be made toU.S. Provisional Patent Application No. 62090136 entitled “MEMBRANE ANDBALLOON SYSTEMS AND DESIGNS FOR CONDUITS” filed on Dec. 10, 2014,incorporated herein by reference in its entirety for at least itsdiscussion of size, shape, and placement of the balloon within an EAC ofa user.

The illustrated wearable monitoring device 20 includes one or more ofthe following: a sensor 5A in the form of at least one physiologicalsensor or at least one environmental sensor (which can include anacoustical sensor or a motion sensor) (and in some instances can also bereferred to as an external energy sensor) housed on or within a housingof the device 20 (and optionally or additionally houses externalthereto), at least one signal processor 4, at least onetransmitter/receiver 6A, 6B, or 6C, at least one power source 2, atleast one body attachment component 21 which can be an inflation elementor balloon and which can include one or more of the other elements ofthe wearable monitoring device 20, and at least the housing. The housingcan include the main body housing 23 and a stent or extension 22 as wellas a flange 24 and can further include the inflation element or balloon21. The housing can further include an end cap 25 which can furthercarry or incorporate a capacitive or resistive sensor 26 or opticalsensor as shown in FIG. 2B and 2C. The main housing portion 23 can alsoinclude a venting port 23A to enable additional venting between theflange 24 and the balloon 21 when the device 20 is inserted within EAC.The sensor 26 can be used to detect gestures in ad hoc or predeterminedpatterns or in yet another embodiment the sensor 26 can alternatively bea fingerprint type of sensor. The inflation element or balloon 21 caninclude, incorporate, carry or embed one or more sensors such as asurface acoustic wave or SAW sensor 21A that can be used for measuringblood pressure. In one embodiment, a balloon having conductive traces onthe surface of the balloon to serve as the surface acoustic wave sensorcan be used for measuring blood pressure. Further note that the stent orextension 22 protrudes or extends through the balloon 21 and terminatesat an end 22A of the extension 22A. The end 22A is the portion of thedevice 20 that would be inserted in the direction to the user's tympanicmembrane and can include one or more sensors such as an ear canalmicrophone and/or thermometer. The end 22A can include acoustic portsfor an ear canal microphone and ambient microphone(s) as well as portsfor accomodating additional sensors such as thermometers as will befurther shown in later illustrations. Though the health andenvironmental sensor functionality can be obtained without thecommunication transceivers (6A, 6B, or 6C), having these additionalmodule(s) may promote use of the wearable monitoring device 20 by users.The illustrated wearable monitoring device 20 is intended primarily forhuman use; however, the wearable monitoring device 20 may also beconfigured for use with animals. In one preferred embodiment, thewearable monitoring device 20 is an earpiece module attached to the earor for insertion within an ear canal of the human ear. In anotherpreferred embodiment, the wearable monitoring device 20 is an earpiecemodule attached in to the ear canal of a cow, horse, or dog. In someembodiments, the wearable monitoring device 20 is inserted in theexternal auditory canal (EAC) and fixed to the EAC using the expandableelement or balloon. The expandable element or balloon can occlude orsubstantially occlude the EAC to provide an environment that issubstantially free of ambient noise.

A physiological sensor (5A) can be any compact sensor for monitoring thephysiological functioning of the body, such as, but not limited to,sensors for monitoring: heart rate, pulse rate, breathing rate, bloodflow, heartbeat signatures, cardio-pulmonary health, organ health,metabolism, electrolyte type and concentration, physical activity,caloric intake, caloric metabolism, metabolomics, physical andpsychological stress levels and stress level indicators, physiologicaland psychological response to therapy, drug dosage and activity (drugdosimetry), physiological drug reactions, drug chemistry in the body,biochemistry, position & balance, body strain, neurological functioning,brain activity, brain waves, blood pressure, cranial pressure, hydrationlevel, auscultatory information, auscultatory signals associated withpregnancy, physiological response to infection, skin and core bodytemperature, eye muscle movement, blood volume, inhaled and exhaledbreath volume, physical exertion, exhaled breath physical and chemicalcomposition, the presence, identity, and concentration of viruses &bacteria, foreign matter in the body, internal toxins, heavy metals inthe body, anxiety, fertility, ovulation, sex hormones, psychologicalmood, sleep patterns, hunger & thirst, hormone type and concentration,cholesterol, lipids, blood panel, bone density, body fat density, muscledensity, organ and body weight, reflex response, sexual arousal, mentaland physical alertness, sleepiness, auscultatory information, responseto external stimuli, swallowing volume, swallowing rate, sickness, voicecharacteristics, tone, pitch, and volume of the voice, vital signs, headtilt, allergic reactions, inflammation response, auto-immune response,mutagenic response, DNA, proteins, protein levels in the blood, bodyhydration, water content of the blood, pheromones, internal body sounds,digestive system functioning, cellular regeneration response, healingresponse, stem cell regeneration response, and the like. Vital signs caninclude pulse rate, breathing rate, blood pressure, pulse signature,body temperature, hydration level, skin temperature, and the like. Aphysiological sensor may include an impedance plethysmograph formeasuring changes in volume within an organ or body (usually resultingfrom fluctuations in the amount of blood or air it contains). Forexample, the wearable monitoring device 20 may include an impedanceplethysmograph to monitor blood pressure in real-time. Note that one ormore of these physiological sensors can be incorporated within or on theexpandable element or balloon.

An external energy sensor (5A), serving primarily as an environmentalsensor, can be any compact sensor for monitoring the externalenvironment in the vicinity of the body, such as, but not limited to,sensors for monitoring: climate, humidity, temperature, pressure,barometric pressure, pollution, automobile exhaust, soot density,airborne particle density, airborne particle size, airborne particleshape, airborne particle identity, volatile organic chemicals (VOCs),hydrocarbons, polycyclic aromatic hydrocarbons (PAHs), carcinogens,toxins, electromagnetic energy (optical radiation, X-rays, gamma rays,microwave radiation, terahertz radiation, ultraviolet radiation,infrared radiation, radio waves, and the like), EMF energy, atomicenergy (alpha particles, beta-particles, gamma rays, and the like),gravity, light properties (such as intensity, frequency, flicker, andphase), ozone, carbon monoxide, greenhouse gases, CO2, nitrous oxide,sulfides, airborne pollution, foreign material in the air, biologicalparticles (viruses, bacteria, and toxins), signatures from chemicalweapons, wind, air turbulence, sound and acoustical energy (both humanaudible and inaudible), ambient noise, ultrasonic energy, noisepollution, human voices, animal sounds, diseases expelled from others,the exhaled breath and breath constituents of others, toxins fromothers, bacteria & viruses from others, pheromones from others,industrial and transportation sounds, allergens, animal hair, pollen,exhaust from engines, vapors & fumes, fuel, signatures for mineraldeposits or oil deposits, snow, rain, thermal energy, hot surfaces, hotgases, solar energy, hail, ice, vibrations, traffic, the number ofpeople in a vicinity of the user, the number of people encounteredthroughout the day, other earpiece module users in the vicinity of theearpiece module user, coughing and sneezing sounds from people in thevicinity of the user, loudness and pitch from those speaking in thevicinity of the user, and the like.

In some embodiments, a physiological sensor and/or an environmentalsensor may be configured to identify a person, such as biometricidentification of a person, to whom the wearable monitoring device 20 isattached (or may be configured to identify other persons in the vicinityof the person wearing the monitoring device 20). In some embodiments,the wearable monitoring device 10 can be used for multimodal voiceauthentication or for voice identification such that multiple sensors(acoustic, heart signature, fingerprint, etc.) can provide a more robustor secure authentication or identification. Voice identification can bedone among a group of known existing voice identities or profiles.

In some embodiments, a physiological sensor and/or an environmentalsensor may be configured to monitor physical aging rate (relative to anactual age) of a person or subject. Aging rate can be assessed from ananalysis of any of a number of parameters including, but not limited tocell density, heart signature, voice acoustics, lung function, a levelof mobility, blood pressure, body composition, blood pressure, and otherinformation that can be obtained from a user profile. The signalprocessor 4 may be configured to process information from aphysiological sensor and/or an environmental sensor or other sensors toassess aging rate. Physiological sensors configured to assess aging ratemay include pulse rate sensors, blood pressure sensors, activitysensors, and psychosocial stress sensors. Environmental sensorsconfigured to assess aging rate may include UV sensors and pollutionsensors.

In some embodiments, a physiological sensor 11 can be configured toreceive brain wave activity and in some embodiments a balloon can beused to receive such brain wave activity and to optionally transmit tothe brain as the device is enclosed in the ear canal and has anefficient path for wave propagation. More particularly, the devicelocation can reside at or in close proximity to the skull in a softtissue area. In some embodiments, the balloon can use an EMI fluid toshield against stray emissions entering into the canal that cancompromise the desired or intended brain wave signal. In someembodiments the entire balloon can be filled with EMI fluid and in yetother embodiments on a portion of a balloon or compound balloon caninclude the EMI fluid. In some embodiments, a balloon can be produced toinclude a “pocket” (or separate chamber) which can be filled with a EMIfluid. In the case of reducing stray EMI from entering in to the earcanal, the pocket would be on the superior or proximal end of theballoon (the area closest to the orifice and exterior), as the distalend (or area closest to the tympanic membrane or skull) of the balloonwould be used for wave propagation in to the EAC and any EMIcharacteristics could preclude efficient acquisition and or transmissionof brain wave propagation. Thus, in one embodiment, the balloon portionplaced nearest the tympanic membrane or skull would not include the EMIfluid and the balloon portion (or pocket) closest to the orifice wouldinclude the EMI fluid. In some embodiments where acquisition ortransmission of brainwaves is not an issue or concern, then a singleballoon with EMI fluid can be used.

In some embodiments, a physiological sensor and/or an environmentalsensor may be configured to be regenerated through a physical and/orchemical change. For example, it is anticipated that a wearablemonitoring device 20, or other device incorporating physiological and/orenvironmental sensors according to embodiments of the present invention,may be coupled to an apparatus that is configured to “recharge” orregenerate one or more environmental and/or physiological sensors via aphysical process or a chemical process, etc. For example, a rechargingmodule for recharging electric power to the wearable monitoring device20 may also user electrical energy to reverse a chemical or physicalchange in one of the sensors. One example of such a sensor would be asensor that requires the absorption or desorption of water vapor forresetting to baseline operation. Another example is a sensor that isreset (recharged) through oxidation or reduction in order to change thesurface properties for monitoring vapors, such as some metal oxidesensors.

Because the wearable monitoring device 20 is capable of measuring andtransmitting sensor information in real-time over a duration of time,the physiological and environmental sensors (5A) can be used to sensethe aforementioned parameters over time, enabling a time-dependentanalysis of the user's health and environment as well as enabling acomparison between the user's health and environment. Combined withproximity or location detection, this allows an analysis for pinpointingthe location where environmental stress and physical strain took place.

Proximity detection can be accomplished through GPS type devicesintegrated into the monitoring device 20 or a personal communicationdevice (cell phone) or other GPS device (such as a GPS wristwatch) incommunication with the monitoring device 20. Proximity detection canalso be accomplished through triangulation of wireless signals; if acellular phone is used as the personal communication device, proximitycan be identified through existing cellular infrastructure foridentifying the time and location of a phone call. Proximity can also bedetermined through beacon IDs for registered local wireless basestations such as local WiFi base stations at known locations.

The signal processor 4 provides a means of converting the digital oranalog signals from the sensors into data that can be transmittedwirelessly by the transmitter 6A-C. The signal processor 4 may becomposed of, for example, signal conditioners, amplifiers, filters,digital-to-analog and analog-to-digital converters, digital encoders,modulators, mixers, multiplexers, transistors, various switches,microprocessors, or the like. For personal communication, the signalprocessor 4 processes signals received by a wireless communicationreceiver into signals that can be heard or viewed by the user. Thereceived signals may also contain protocol information for linkingvarious telemetric modules together, and this protocol information canalso be processed by the signal processor 4 or alternatively by a remoteprocessor or server (not shown).

The signal processor 4 may utilize one or more compression/decompressionalgorithms (CODECs) used in digital media for processing data. Thecommunication modules (6A-C) can be comprises of one or transmittersthat can be a variety of compact electromagnetic transmitters. Astandard compact antenna can be used in the standard Bluetooth® headsetprotocol, but any kind of electromagnetic antenna suitable fortransmitting at human-safe electromagnetic frequencies may be utilized.The communication modules (6A-C) can also include a communicationreceiver that can also include an antenna. In some embodiments, thereceiving antenna and the transmitting antenna are physically the same.The receiver/transmitter can be, for example, a non-line-of-sight (NLOS)optical scatter transmission system. These systems typically useshort-wave (blue or UV) optical radiation or “solar blind” (deep-UV)radiation in order to promote optical scatter, but IR wavelengths canalso be used.

Additionally, a sonic or ultrasonic transmitter can be used as thereceiver/transmitter of the wearable monitoring device 20, butpreferably using sounds that are higher or lower than the human hearingrange. A variety of sonic and ultrasonic receivers and transmitters areavailable in the marketplace and may be utilized in accordance withembodiments. If a telecommunication device receiving wireless datasignals from the wearable monitoring device 20 is in close proximity tothe wearable monitoring device 20, and the wearable module is anearpiece module, a variety of transmission schemes can be used. Forcommunicating audible conversational information directly to theearpiece user, encoded telemetric conversational data received by thereceiver can be decoded by the signal processing module 4 to generate anelectrical signal that can be converted into audible sound.

In some embodiments, the transmitter/receiver (6A-C) is configured totransmit signals from the signal processor 4 to a remote terminalfollowing a predetermined time interval. For example, the transmittermay delay transmission until a certain amount of detection time haselapsed, until a certain amount of processing time has elapsed, etc. Insome cases, the transmitter/receiver is configured to transmit signalsto the remote terminal dependent on information sensed by the sensors(5A). For example, if an unstable pulse rate is sensed, a warningmessage may be sent to a remote terminal to communicate a need for helpat a particular location as determined by a GPS device operativelycoupled to the device 20.

The power source can be any portable power source 2 capable of fittinginside the housing 23. According to some embodiments, the power source 2is a portable rechargeable lithium-polymer or zinc-air battery.Additionally, portable energy-harvesting power sources can be integratedinto the wearable monitoring device 20 and can serve as a primary orsecondary power source. For example, a solar cell module (as will befurther detailed) can be integrated into the wearable monitoring device20 for collecting and storing solar energy. Additionally, piezoelectricdevices or microelectromechanical systems (MEMS) can be used to collectand store energy from body movements, electromagnetic energy, and otherforms of energy in the environment or from the user himself Athermoelectric or thermovoltaic device can be used to supply some degreeof power from thermal energy or temperature gradients. In someembodiments, a cranking or winding mechanism can be used to storemechanical energy for electrical conversion or to convert mechanicalenergy into electrical energy that can be used immediately or stored forlater. Further note that the power source 2 can be incorporated or bepart of the inflatable element or balloon 21. Biocompatible batterychemistry can be used within the balloon for biological applications andother battery chemistries can be used when non-biological applicationsare considered.

Referring to FIGS. 2K and 2L, an earpiece 20 with further details ofcomponents are shown. FIG. 2K illustrates an earpiece 20 without anendcap (25) as shown in FIG. 2L. The earpiece 20 includes the balloon21, fluid 21C that fills the balloon, a main housing portion 23 thathousing a speaker 27, a battery 28, a first ambient microphone 32, asecond ambient microphone 34, a valve 31 for controlling the flow offluid in and out of the balloon 21, and a recharging coil 29 using forinductively recharging the battery 28. The microphones 32 and 34, andvalve 31 are set in place and mated with respective openings within theend cap 25 as shown in FIG. 2L. The End cap 25 also covers therecharging coil 29. The end cap 25 can also include a capacitive sensor(not shown in FIG. 2L, but see FIGS. 2B, 2C, 6E, and 8C).

The various components described above are configured to fit within ahousing of the wearable monitoring device 20 and/or be attached thereto.In the case where the wearable monitoring device 20 is an earpiecemodule, the housing may be formed from any safe and comfortable solidmaterial such as metal, rubber, wood, polymers, ceramic, organicmaterials, or various forms of plastic. In some embodiments, the housingcan be made of a flexible and pliable medical grade of silicone that canconform or bend as the earpiece traverses the orifice and EAC of theuser during insertion and removal of the device 20. Further note that insome embodiments the electronics can be housed separately such that thebody attachment component or balloon 21 can be separated active orelectronic components of the device 20. In other words, the device 20can be made in a manner that enables the balloon 21 to be replaceable.Alternatively, the active component portion can also be viewed as beingreplaceable.

The body attachment component or balloon 21 is attached to the remaininghousing and is designed to fit within the EAC and alternatively aroundor near the ear in other embodiments. In some embodiments, the bodyattachment component (or balloon 21) can contain physiological andenvironmental sensors, and the main housing components may bedetachable. In some embodiments, different modules having differentsensors as part of the balloon or as part of the main housing can beattached to the remaining components in a modular fashion. In manyinstances, the processor can be within the main housing and the balloon21 can have various alternative sensor configurations for use with theactive components resident in the main housing. As noted above, theearpiece attachment can simply be an inflatable element or balloon asfurther illustrated in FIG. 8C for example.

The communication module is used for, but not limited to: processing orgenerating an audible sound from information received via the receiver(from a cell phone, computer, network, database, or the like) and/orprocessing or generating an electrical signal from an audible sound fromthe user such that the electrical signal can be transmittedtelemetrically via the transmitter. For example, in standard Bluetooth®protocol, communication electronics are used to convert an audibleconversation into an electrical signal for telemetric conversation;communication electronics are also used to convert a digitizedtelemetric conversation into an audible conversation for the earpieceuser. Additionally, the communication module can be used to store,process, or play analog or digital information from music, radio shows,videos, or other audible entertainment and to communicate thisinformation to an earpiece user. In many cases, this informationincludes information received by the receiver. In many cases, the analogor digital information is not stored in the communication module 17 but,rather, is stored in a portable telecommunication device such as a cellphone. In such case, the communication module is used for converting theanalog or digital information into audible sound for the earpiece user.The communication module may contain at least one microphone, speaker,signal processor, and digital memory. In some embodiments, thecommunication module may apply at least one CODEC for encoding ordecoding information. The communication module may utilize non-audibleforms of communication with the user, such as visual, physical, ormental (i.e., brainwaves or neural stimulation) communication with theuser.

In some embodiments, an audible communicator is provided that isconfigured to communicate therapeutic sounds (e.g., music therapy, etc.)to a person in response to physiological or psychosocial stress. Theaudible communicator may be embodied in the communication module or maybe a separate speaker. In some embodiments, light therapy may beprovided to a person in response to physiological or psychosocialstress. In some embodiments, the communication module may be configuredto communicate a treatment, therapy, and/or plan of action to the personupon detection of physiological and/or environmental concerns. Forexample, if it is detected that the person is being exposed to unhealthydoses of UV radiation, the communication module may audibly instruct theperson to move away from the person's current location (e.g., moveindoors, etc.). Mechanical vibrational therapy and electricalstimulation therapy are also examples of automated therapies that may beinvoked by programs inside the monitoring device 20 in response tosensor readings from health and/or environmental sensors.

Like the other components of the wearable monitoring device 20 shown inFIG. 1, the components of the communication module are not necessarilylocated in the same physical vicinity. The microphone and speaker of thecommunication module, for example, may be located closer to the mouthand ear respectively. Furthermore, the signal processor 4 can becomposed of several components located throughout the earpiece. Itshould be understood that the word “module” does not necessarily imply aunified physical location. Rather, “module” is used to imply a unifiedfunction.

Bluetooth® devices conventionally contain a communication module, suchas communication module, for converting digital or analog informationinto audible sounds for the user. However, when combined with the healthand environmental monitoring properties of a wearable monitoring device20 according to embodiments, the communication module can providefunctionality. For the wearable monitoring device 20 can serve as abiofeedback device. As a non-limiting example, if a user is in apolluted environment, such as air filled with VOCs, the communicationmodule may notify the user to move to a new environment. As anotherexample, if one or more of the physiological and environmental sensors(5A) of the wearable monitoring device 20 pick up a high particulatedensity in the environment, with an elevation in core body temperature,and a change in voice pitch occurring simultaneously (ornear-simultaneously) within a common timeframe, the communication modulemay alert the user that he/she may be having an allergic response. As afurther example, the user can use the communication module to executebiofeedback for willfully controlling blood pressure, breathing rate,body temperature, pulse rate, and the like. The communication module mayutilize audible or visible alerts if the user is meeting theirphysiological targets or exceeding safe physiological limits. Alerting auser by physical or electrical force, such as the sense of touch ortingling from an electric pulse or vibration, can also be utilized.Thus, although communication by audible means is often utilized, thecommunication module can alert, signify, or communicate with the userthrough sound, light, electrical actuation, and physical actuation.

As a second example of this biofeedback method, basic vital signscollected by the physiological sensors 5A and processed by the signalprocessor 4 can be presented to the monitoring device user audibly,through the communication module. For example, the user may be able tolisten to his/her breathing rate, pulse rate, and the like.Additionally, an entertaining or aggravating sound or song can be usedto alert the user to favorable or unfavorable personal health andenvironmental factors occurring in real-time. This technique may beapplied towards education, such as positive or negative feedback foreducational games, learning games, or games of deception (e.g., poker,etc.). FIG. 9 illustrates the display of physiological information andenvironmental information collected by a monitoring device 20 via auser's cell phone, according to some embodiments.

In some embodiments, the wearable monitoring device 20 may be configuredto deliver and/or monitor drugs, as in a dosimeter. For example, atransdermal drug delivery system may be provided that is controlled bymonitoring device 20 electronics. Physiological sensors can monitor thedrug dosage and the physiological effects of the drug in real-time.Similarly, sound pressure level (SPL) monitoring using microphones and aprocessor can monitor the SPL dosage or exposure to an individualwearing the device 20.

A health and environmental monitoring system according to embodimentsthat may incorporate wearable monitoring devices 20 of FIG. 1 isillustrated in part in FIGS. 2M and 2N for example. Other types ofwearable monitoring devices may also be utilized in the health andenvironmental monitoring system. The wearable monitoring device 20 isutilized as a specific monitoring device of the monitoring system,though other modules located at various other parts of the body can beused in conjunction with, or in place of, the wearable monitoring device20. The terms “wearable monitoring device” and “sensor module” are usedinterchangeably herein in accordance with various embodiments. Thehealth and environmental monitoring system is composed of at least onesensor module (e.g., wearable monitoring device 20) at least oneportable telecommunication module that can be part of the monitoringdevice or be part of a communications device operatively coupled to thedevice 20 such as a cell phone, at least one transmission system such asa Bluetooth module, at least one user interface, at least one personaldatabase, and at least one anonymous database.

Internally, the device 20 in some embodiments can include a balloonfilled with fluid 21C that traverses a channel and controlled or filledthrough a valve 31. The balloon can be pre-filled to a predeterminedpressure level. The device 20 can further include a memory 33 forstoring user profiles, sensor data, communication data, sound data,control data, or algorithms and applications used in the extraction andanalysis of sensor data or other aforementioned information. A flexcircuit 35 can be utilized to provide the appropriate electricalconnections between the various components and sensors in the device 20.The device further includes a processor such as a digital signalprocessor 36 that can perform an number of functions including, but notlimited to acoustic processing, hearing loss correction, receiving orextracting sensor data, analog to digital conversion, digital to analogconversion, and filtering of signals. The device can further include oneor more ambient microphones 32 and 34, a speaker 27, an ear canalmicrophone 39, and a battery 28. An inductive coil 29 can be mounted orcoupled to the battery housing to enable inductive charging of thebattery 28. The device 20 can further include several non-acousticsensors such as capacitive pads 21D used for ECG monitoring, athermometer 37 for measuring temperature at or near the user's skull,and a SAW sensor 21A used for blood pressure sensing. The device canalso include one or more LEDs 38 used for blood oximetry.

FIG. 3 illustrates a close up of area including the battery 28 andrecharging coil 29. The close-up view of FIG. 3 does not include the endcap (25), but does include the flange 24 which protects a number ofother components in the device 20 including the ambient microphones 32and 34, the valve 31, the flex circuit 35 and an indicator LED 39. Theindicator LED 39 can be configured to emit at least one or moredifferent lights and/or flashing patterns to provide an indication of acharging mode, a recording mode, a full charge state, or anotheroperational state.

The sensor module 5 or 5A of FIG. 1 can be composed of a primary modulealone or a primary module and at least one secondary module. The primaryand secondary modules can be located at any location of the body, but inmany cases it is preferable to be located in a region at or near theear, and preferably the wearable monitoring device 20 serves as theprimary module. In many cases, the secondary modules are not necessary.But in some cases, secondary modules may be located, for example, behindthe ear (near the lymph nodes), at or near the earlobes (such as one ormore earrings or ear clips), at the front of the ear (near the carotidartery), at the temples, along the neck, or other locations near theear. In some cases the secondary modules, as with the primary module,can be located inside the body. These wearable secondary modules can beconnected with either a “hard” connection to the primary module (such asan electric cable) or a “soft” connection to the primary module (such asa wireless connection). In Bluetooth® protocol, each secondary modulecan be simultaneously in direct wireless communication with the primarymodule. Primary modules and secondary modules in the same location canpromote quick-donning, ease-of-use, and comfortability for the end user.Users may not be prone to accept multiple modules at multiple locationsof the body. A primary module can be on the device 20 and a seconddevice can reside on a separate device such as a mobile device or phoneor another body worn device in operational communication with the device20. The mobile device can be any portable device, such as a cell phone(which includes a “smartphone”), PDA, laptop computer, Blackberry,another earpiece, or other portable, telemetric device. The mobiledevice and the wearable sensor module 20 can telemetrically communicateboth to and from each other. Though the main purpose of the portabletelecommunication device is to transmit the local wireless signal fromthe sensor module 20 over longer distances unattainable by thetransmitter of the sensor module 20, the telecommunication device canalso serve as a method of personal communication and entertainment forthe earpiece user.

In some embodiments, referring back to FIGS. 1A and 1B, atelecommunication device 6D transmits data in only one direction orparticular directions. For example, in one embodiment, the portabletelecommunication device 6D can receive telemetric information from thesensor module 1 but is not configured to send out signals to atransmission system. The portable telecommunication device 6D may alsocontain an end-user graphical interface, such as a user interface 121(shown in FIG. 12) in the monitoring system, such that data from thewearable sensor module 1 can be stored, analyzed, summarized, anddisplayed on the portable telecommunication device 6D. For example,charts relating health and environment, as well as real-time biofeedbackand the like, can be displayed on a cell phone, media player, PDA,laptop, or other device (6D). The telecommunication device 6D may alsocontain physiological and environmental sensors itself, such as sensorsfor blood pressure, pulse rate, air quality, pulse-oximetry, and thelike. Additionally, the telecommunication device 6D can communicate withthe wearable sensor module 1 to transfer commands, activate ordeactivate sensors, communicate with the user, and the like.

In some embodiments, the portable telecommunication device 6Dsends/receives wireless information directly to/from a transmissionsystem for transmission to a database (such as personal database and/oranonymous database on a server 7E or 7C) for storage, analysis, andretrieval of data. The style of transmission system may depend largelyon the location of the database. For example, if the database is locatedin a local computer, the wireless information from the telecommunicationdevice 6D can be sent directly to the local computer. This computer maybe connected with the Internet, allowing access to the database from theweb. However, the database is more typically located far away from theuser and telecommunication module. In this case, the wireless signalfrom the telecommunication device 6D can be sent to a reception towerand routed through a base station (not shown). This information can thenbe sent to a database through the Internet. A variety of othertransmission protocols can be applied for connection between thetelecommunication device 6D and the databases 7E.

The personal and anonymous databases 7E represent databases that may ormay not be located on the same computer. A difference between these twodatabases is not the physical location of the database but rather thetype of information available on each database. For example, theanonymous database, containing aggregated health and environmental datafrom multiple indistinct monitoring device users, can be public andaccessible through the Internet by various users. In contrast, thepersonal database contains health and environmental data that ispersonalized for each monitoring device user, including personalizedinformation such as name, birth date, address, and the like. Users canlog-in to their personalized information in the personal databasethrough an interactive user interface and compare this information withinformation from multiple users in the anonymous database via agraphical user interface, etc. In some cases, the wearable sensor module1 or 20 (FIG. 1A or 2A-N) or portable telecommunication device 6D mayadditionally communicate information not directly related to health andenvironment, such as physical location, personal information, proximityto various locations or properties, etc., to either database. In somecases, this additional information may be sensed by the wearable sensormodule 1 or 20 and/or by sensors and/or protocols integrated intoportable communication device 6D.

The user interface 120 (see FIG. 12) can be a computer monitor, a cellphone monitor, a PDA monitor, a television, a projection monitor, avisual monitor on the wearable sensor module 20, or any method of visualdisplay. For hands free operation and reduced distraction, audiblemethods and audio-visual methods can also be used for the user interfaceas part of the earpiece 20 itself (as well as mechanical methods such asautomated brail displays for the blind.) For example, the user maylog-in to their personal database through a computer user interface andcompare real-time personal health and environmental exposure data withthat of other users on the monitoring system. In some cases, the datafrom other users may be anonymous statistics. In some cases, one or moreusers may have agreements to view the data of one or more other users,and in other cases, users may agree to share mutual personalized datathrough the Internet.

The monitoring system 20 can be used in medicine for a variety ofimportant functions. As one example, a doctor can monitor the health ofpatients through each patient's personalized database. If the wearablesensor module 20 contains a dosimeter, the doctor can even monitor theefficacy of prescribed medications, and the physiological response tomedications, over time. This dosimetry approach is directly applicableto clinical studies of various treatments. For example, during aclinical trial, the wearable sensor module 20 can collect environmentaldata, drug dosimetry data, and physiological data from the earpiece usersuch that researchers can understand the epidemiology between drugs,genes, physiology, environment, and personal health.

The monitoring system 20 can be used by athletic trainers to monitor thediet, physical activity, health, and environment of athletes. In manycases professionals are not necessary, and the user can monitor his/herown diet, activity, athletic performance, etc. through the monitoringsystem without professionals, parents, guardians, or friends monitoringtheir personal statistics.

In other instances, first responders, soldiers, and other securitypersonnel can be monitored for mission or battle readiness, mental andpsychological aptitude towards a task, or for physical or psychologicalconditions warranting an emergency rescue or other assistance all in aneffort to provide added safety, security, authentication, andsurvivability. A police officer or other official in a hostagenegotiation may exhibit biometric signatures indicative of extremenervousness or collapse in the midst of a negotiation and may requireassistance or a replacement negotiator. In another scenario woundedsoldier or police officer or crime victim may exhibit low blood pressureas a result of a gunshot wound or other injury. A potential rape orassault victim may exhibit an elevated heart rate and/or blood pressureand speak certain key words that can trigger a signal for assistance bythe police or other authorities.

It should be noted that algorithms for processing personal health andenvironmental data, diagnosing medical conditions, assessing healthstates, and the like do not need to be limited to the illustratedmonitoring system 20. Various algorithms can also be integrated into thewearable sensor module 20 or telecommunication device 6D according toembodiments of the present invention. A data storage component in atleast one of these units allows processed signal data to be stored,analyzed, and manipulated to provide new knowledge to the user or keepit blind to the user as is the case for 3-party examination. Thisstorage component can be any solid-state storage device, such as flashmemory, random-access memory (RAM), magnetic storage, or the like. Forexample, the wearable sensor module 1 or 20 can be programmed to monitorcertain habits, such as nail biting or snoring by comparing with soundsignatures or profiles for such habits. In this non-limiting example,the physiological sensors 5 or 5A may monitor internal sounds, and analgorithm can be implemented to monitor signatures of nail biting orsnoring sounds in real-time. If the habit is identified by a soundsignature detection algorithm, the wearable sensor module 1 or 20 mayinstantly warn the user that the habit is occurring. Alternatively, thealgorithm may count the number of times a day the habit occurred,monitor physiological and psychological stress indicators during eachoccurrence, log each time when the habit occurred, and storeenvironmental data associated with the habit. This stored data can beaccessed at a later time, allowing the user to determine whatenvironmental factors cause the physiological or psychological stressassociated with nail-biting or snoring. As this example shows, thesealgorithms can take advantage of both physiological sensor data andenvironmental sensor data.

In another example, the physiological sensors can be used to performtransdermal ethanol detection to prevent drunk driving if integratedinto an ignition interlock system for example. However, experimentaldata from previous research has shown significant time delays betweenalcohol ingestion and detection at the skin which makes real timeestimation of blood alcohol concentration via skin measurementdifficult. A computational model that predicts the lag time between peakblood and skin alcohol concentrations can enable better accuracy.Accounting for how the lag time varies with ethanol dose, body weightand metabolic rate can possibly improve transdermal alcohol sensing fordetecting driver BAC for different segments of the population and levelsof intoxication.

Notwithstanding the current inaccuracies in trying to measure BAC inreal time, transdermal measurements can prove useful as a dichotomoustest to sense if the driver has been consuming alcohol. Additionally, aneasy way to circumvent a transdermal measurement would be to blockdirect skin contact with the sensor. An intoxicated driver wearinggloves could potentially prevent the sensors for detecting any ethanolon their skin at all. A secondary sensor system would be required toensure that the measurement is being made at the surface of the skin. Anearpiece having such a sensor can serve as such a measurement device.

Transdermal sensing of the alcohol in a driver's blood is one possibleway to non-invasively detect intoxicated drivers. However, thefeasibility of this method suffers from the time delay required for thealcohol in the driver's blood to diffuse to the surface of the skinwhere it can be easily and non-invasively measured. It has been foundthat, for a given dose of alcohol, lag time is insensitive to bodyweight. However, the dose size has a significant impact on theblood-skin concentration lag. A larger dose of alcohol causes anincrease in the lag time. A 15 ml dose of 95% ethanol given to allpercentile drivers was found to have a lag time of approximately 33minutes. Quadrupling the dose to 60 ml of ethanol increases the lag timeto approximately 53 minutes. Using transdermal sensing of real-time BACusing only skin surface measurements may prove to be very challenging,but models can be discovered that provides a better correlation amongvarious parameters being measured to provide a more accurate system. TheEAC offers such a location.

In the context of a device enabling a vehicle ignition, the transdermalmeasuring device can be used in conjunction with other validating testsor measurements to determine sufficient competency to operate suchvehicle. For example, an airline pilot, ferryboat driver, cruise shipoperator, or crane operator can have other physiological measurementsmonitored if a minimal threshold alcohol level is detected. For example,a microphone and associated processor can monitor and detect slurredspeech which can be an indication of alcohol consumption or some otherform of impairment. In some embodiments, the transdermal sensor in anearpiece can further utilize motion detectors to sense conformance withmotions typically given in a standard field sobriety test. For example,in one such system, if the ignition system and/or sensor detects aminimum alcohol level, the earpiece or vehicle sound system can providean auditory request that the user perform one or more field sobrietytests such as the Horizontal Gaze Nystagmus (NGN), Walk-and-Turn (WAT),or One-Leg Stand (OLS). A motion sensor, accelerometer, gyroscope, GPSdevice or other motion detection scheme can be used to confirmconformance with any one of the field sobriety tests or other motiontests. In this manner, operation of the vehicle in a unsuitablecondition is avoided, particularly if the condition is triggered by asuspicion of alcohol use. Operators of public transportation or otherinherently dangerous vehicles can be held and accounted for a higherstandard using the means outlined herein.

In another aspect, the transdermal sensor in an earpiece can be used ina social setting to enable individuals in a social network to monitor awearers' levels alcohol throughout a period of time or evening and willperiodically provide haptic feedback to the wearer to check in and makesure they are conscious and adequately in control. If no response isprovided by the wearer or a response indicative of a medical conditionor other emergency is determined, the earpiece can send a signal thatcan alert others in the wearers' social network to facilitate assistancefrom one or more individuals in the network. Location can be determinedusing GPS information or triangulation of the signaling.

According to some embodiments of the present invention, physiologicaland/or environmental information collected from a person can be analyzedto identify a source of stress to the person, and one or more solutionsfor reducing stress can be recommended to the first person, for examplevia the monitoring device 20 (or in other ways).

A data storage component may include various algorithms, withoutlimitation. In some embodiments, at least one algorithm is configured tofocus processing resources on the extraction of physiological and/orenvironmental information from the various environmental and/orphysiological sensors. Algorithms may be modified and/or uploadedwirelessly via a transmitter (e.g., receiver/transmitter of the wearablemonitoring device 20)

The biofeedback functionality of the telemetric wearable monitoringdevice 20 can be applied towards various gaming applications. Forexample, one or more subjects can connect their wearable monitoringdevices 10 to one or more gaming devices wirelessly through the openarchitecture network provided by Bluetooth®, ZigBee, or other suchnetworks. This allows personal health and environmental information tobe transferred wirelessly between the wearable monitoring device 20 anda gaming device. As subjects play a game, various personal health andenvironmental feedback can be an active component of the game. In anon-limiting embodiment, two users playing a dancing game, such as JustDance, can monitor their vital signs while competing in a dancingcompetition. In some cases, users having healthier vital signs, showingimproved athletic performance, will get extra points (“Vital Points”).In another specific example, this personal health and environmentalinformation can be sent telemetrically to a gaming device to makeentertaining predictions about one or more users. Namely, the gamingdevice may predict someone's life expectancy, love-life, futureoccupation, capacity for wealth, and the like. These predictions can betrue predictions, purely entertaining predictions, or a mixture of both.Sensors measuring external stressors (such as outside noise, lightingconditions, ozone levels, etc.) and sensors measuring internal stresses(such as muscle tension, breathing rate, pulse rate, etc.) integratedinto the wearable monitoring device 20 can be used to facilitatepredictions by the gaming device.

Physiological and/or environmental information collected from sensors 5or 5A in a wearable module 1 or 20 may be corrupted by the motionartifacts of a subject. As a specific example, when measuring pulse ratein a subject via photoplethysmography while the subject is walking,optical scatter associated with footstep-related skin vibrations may bemisinterpreted as coming from a pulse. This problem can be especiallydifficult where footstep rates are on the order of normal human pulserates. By measuring body motion in real-time via one or moreaccelerometers inside the wearable monitor, sampled pulse rate data canbe processed to subtract, reduce, or eliminate signals associated withfootsteps. In some cases, the processor 4 may simply send a command toignore the sampling and/or logging of pulse rate when body motion isdetected. In this way, average pulse rate estimate is not convolutedwith footstep information. In other cases, the processor 4 may correctfor body motion in real time through dynamic feedback from theaforementioned accelerometer. A variety of other body motion sensors,such as acoustic sensors for monitoring footstep sounds and MEMS motionsensors, can also be used to monitor footsteps and correct physiologicaland/or environmental data for motion artifacts. An important innovationafforded by the databases 25, 26 is that motion artifacts in the datacan be corrected by applying algorithms for reviewing the physiologicaland/or environmental history of each subject, identifying corruptionsassociated with motion artifacts, and extracting physiological and/orenvironmental information from corrupted data. Alternatively, the use ofthe balloon 21 can reliably stabilize the wearable module 1 or 20 withinthe ear canal (EAC) to substantially eliminate such motion artifacts andthereby avoid the need for such corrective algorithms. By not using themotion artifact reducing algorithms, the wearable module 1 or 20 canfurther reduce unnecessary battery or power expenditures and increaseoverall battery life.

A health and environmental monitoring system 20, according to someembodiments of the present invention, enables a variety of additionalbusiness methods for exploiting user information collected by the system20. For example, users can be charged a fee for downloading or viewingdata from the personal and/or anonymous databases. Alternatively, usersmay be allowed free access but may be required to register online,providing personal information with no restrictions on use, for theright to view information from the databases. In turn, this personalinformation can be traded or sold by the database owner(s). Thisinformation can provide valuable marketing information for variouscompanies and government interests. The health and environmental datafrom the databases can be of great value itself, and this data can betraded or sold to others, such as marketing groups, manufacturers,service providers, government organizations, and the like. A web page orweb pages associated with a personal and anonymous database may besubject to targeted advertising. For example, if a user shows a patternof high blood pressure on a personal database, a company may targetblood pressure treatment advertisements on the user interface (i.e., webpage) while the user is logged-in to the personal database through theuser interface. For example, because various health and environmentalstatistics of subjects in the monitoring system 20 will be available onthe database, this information can be used to provide a targetedadvertising platform for various manufacturers. In this case, a databasemanager can sell information to others for targeted advertising linkedto a user's personal statistics. In some cases, a database owner doesnot need to sell the statistics in order to sell the targetedadvertising medium.

According to some embodiments of the present invention, a method ofdelivering targeted advertising to a person includes collectingphysiological and/or environmental information from the person,selecting an advertisement for delivery to the person based upon thecollected physiological and/or environmental information, and deliveringthe selected advertisement to the person. Collecting informationincludes receiving physiological and/or environmental information from amonitoring device associated with the person. Selecting an advertisementincludes analyzing the received physiological and/or environmentalinformation to identify a physiological condition of the person and/orenvironmental condition in a vicinity of the person, and selecting anadvertisement for a product or service related to an identifiedphysiological and/or environmental condition. Delivery of a selectedadvertisement can be via any of many different channels including, butnot limited to, email, postal mail, television, radio, newspaper,magazine, the internet, and outdoor advertising.

A wearable sensor module 20 and health and environmental monitoringsystem can enable a variety of research techniques. For example, aplurality of monitoring devices 20 worn by users can be used inmarketing research to study the physiological and psychological responseof test subjects to various marketing techniques. This technique solvesa major problem in marketing research: deciphering objective responsesin the midst of human subjectivity. This is because the physiologicaland psychological response of the earpiece user largely representsobjective, unfiltered information. For example, users that areentertained by a pilot TV program would have difficulty hiding innatevital signs in response to the program. The data generated by thewearable sensor module 20 during market research can be transmittedthrough any component of the telemetric monitoring system and used bymarketing researchers to improve a product, service, or method.

Another method provided by the monitoring system 20 is to charge usersof the monitoring system for usage and service (such as compilationservice). For example, a clinical trial company may pay a fee foraccessing the databases of their test subjects during medical research.In this case, these companies may buy modules 20 and pay for theservice, or the modules 20 may be provided free to these companies, asthe database service fee can provide a suitable income itself.Similarly, doctors may pay for this service to monitor patients; firefighters and first responders may pay for this service to monitorpersonnel in hazardous environments; and athletic trainers may pay forthis service to monitor athletes. Also, users can pay for the databaseservice directly themselves. Because these databases are dynamic,updated regularly via a wearable sensor module 20 of each user, withdata changing with time for individual users and users en mass, thesedatabases can maintain a long-term value. In other words, there mayalways be new information on the databases.

One innovation involves applying the wearable sensor module 20 towards aphysical or mental health assessment method. An algorithm may combinedata from health and environmental sensors 5 or 5A towards generating apersonal overall health assessment for the user, conditional to aparticular environment. For example breathing rate, pulse rate, and corebody temperature can be compared with ozone density in the air forgenerating an ozone-dependent personal health assessment. In anotherspecific example of this innovation, information from the sensors 5 or5A can be used to monitor overall “mood” of a user in a particularenvironment. More particularly, algorithmic processing and analyzing ofdata from sensors for core body temperature, heart rate, physicalactivity, and lighting condition can provide a personal assessment ofoverall mood conditional on external lighting conditions.

Applying sensor information from the sensor monitoring system 20 towardspredictions for individual subjects and groups of subjects is anotherembodiment of the present invention. Health and/or environmentalinformation from individuals in the monitoring system can be used topredict an individual's behavior, health, the onset of a healthcondition, etc. Collectively, information from multiple subjects in themonitoring system 20 can be used to predict the outbreak of a disease,environmental situation, traffic conditions, mass behavior (such asmarket behavior), and the like. As a specific examples, sensors formonitoring physiological and/or environmental parameters associated withinfluenza may monitor changes in core body temperature, voice pitchchanges, pulse rate changes, etc. in a subject, or group of subjects,wearing a module 20, and this information may be processed into aprediction of the onset of influenza for the subject or group ofsubjects. Indeed, the onset of a mass outbreak can be predicted.

An earpiece/headset form factor for a wearable sensor module 20 can beutilized for monitoring or predicting traffic-related conditions forautomobiles and other vehicles. As a specific example, a wearableearpiece module 20, containing physiological and environmental sensors,can provide information about the stress of a subject while driving, aswell as the speed of the subject, environmental conditions surroundingthe subject, alertness of the subject, and the like. This can beaccomplished by monitoring heart rate, breathing rate, core bodytemperature, acceleration, the weather conditions, air quality, and thelike with sensors 5 or 5A. Information from multiple subjects can beused to track and study the stress of a group of individuals withcertain traffic-related conditions. Additionally, predictions abouttraffic jams, road accidents, traffic flow can be estimated based onprocessed information stored in the remote databases. This informationcan also be used to assist infrastructure decisions that will reduce thestress of drivers, improve traffic flow, and prevent automotiveaccidents. In some cases, this information may be used in studies tounderstand the interaction between stress, road conditions, environment,and the like.

Earpiece monitoring devices described herein need not be embodied withinheadsets only. For example, an wearable earpiece module 20 according toembodiments of the present invention can be a hearing aid, an earplug,eye glasses, an entertaining speaker, the earpiece for an IPOD®,Walkman®, or other entertainment unit, a commercial headset for a phoneoperator, an earring, a gaming interface, body worn jewelry havingcommunications capability, or the like. A wearable earpiece module 20covers the broad realm of earpieces, ear jewelry, and ear apparatusesused by persons for entertainment, hearing, or other purposes bothinside and outside of health and environmental monitoring.

Moreover, two earpiece modules 20 may be utilized, according to someembodiments of the present invention; one for each ear of a person. Insome cases, dual-ear analysis can be performed with a single headsethaving dual earpieces. Dual-ear analysis with two earpiece modules canbe used, for example, to compare the core temperature of each tympanicmembrane in order to gauge brain activity comparing each brainhemisphere. In another case, acoustical energy, including ultrasonicenergy, can be passed from one earpiece module to the other, withacoustic absorption and reflection being used to gauge variousphysiological states. For example, this technique can be used to gaugehydration level in the head or brain by estimating the acoustical energyabsorption rate and sound velocity through the head of the user.

A variety of form factors for wearable monitoring devices 20 may be usedin the embodiments or with the embodiments herein. The form-factor of awrist-watch, belt, article of clothing, necklace, ring, body piercing,bandage, electrode, headband, glasses or sunglasses, cast (i.e., forbroken bones), tooth filling, etc. are but a few examples. A variety ofearpiece styles, shapes, and architectures can be used for the case ofwhere a wearable monitoring device 20 is an earpiece module, accordingto embodiments.

A non-limiting embodiment of an earpiece module is illustrated in FIGS.4A and 4B. The illustrated earpiece 40 fits in the EAC of the ear of aperson and is held in place by a balloon 21 that is sufficient filledwith a fluid with a predetermined pressure. The fluid can be a gas,liquid or gel and preferably a filler that is biocompatible. Theillustrated earpiece module 40 is a wired version and includes a body orhousing that includes a main body housing 23, a flange 41 and anextension or stent 22 to the main body housing 23 that goes through theballoon 21. A portion 22A of the extension or stent 22 that goes throughthe balloon 21 can include acoustic ports and other ports for sensorsand the like. The main body housing 23 can house a speaker 41 and a earcan microphone assembly 42. The module 40 can also include sensors (notshown).

It should be understood that the earpiece 40 can be any shape and sizesuitable for wear in or around or near the ear. In some cases, theearpiece body and earpiece fitting can be one and the same structure,such that the earpiece body-fitting is a small fitting inside the ear.In many or most cases, it is desirable to seal off or partially seal offthe ear canal so as to prevent sounds from entering or leaving the earsuch that an auscultatory signal can more easily be extracted from theear canal through devices (such as microphones) in the earpiecebody-fitting.

FIGS. 5A-C illustrate slight variants of an embodiment of an earpiecemodule 20. FIG. 5A and 5B illustrate an left front perspective explodedview of the earpiece module 20 which includes a balloon 21 filled withfluid 21C and surrounded in part by a SAW based pressure sensor 21A inthe form of metal strips laid on the balloon 21. The module 20 furtherincludes a main body housing 23 having an extension or stent portion 22.The main body housing 23 is enclosed at an opposing end from the stent22 using an end cap 25. Within the main body housing 23 resides aspeaker 27, a flex circuit, a battery 28, and a recharging coil aspreviously described in other embodiments. A flange 24 is slipped overthe balloon 21 during assembly and should appear as in FIG. 2A in finalassembly. FIG. 5C is a right front perspective exploded view of themodule 20. In addition to the items described with respect to FIGS. 5Aand 5B, FIG. 5C further illustrates a valve 31 and fluid channel 21Cused to fill the balloon 21 with fluid 21C. The balloon can also carryone or more LEDs 21E used for blood oximetry and a thermometer 37 formeasuring body temperature near the human skull when the module isinserted within the EAC.

Another multifunctional earpiece module 60, according to embodiments isillustrated in FIGS. 6A-6E. The illustrated earpiece module 60 includessimilar embodiments to those described previously, but in assembledform. FIG. 6A illustrates the module 60 in shaded form and FIG. 6Billustrates the module in a black and white illustration including aballoon 61 coupled to a main housing 63 via an extension or stent 62 ofthe main housing 63. The main housing 63 can include a vent or opening68A that enables the equalization of pressure between the ambient andthe area between the balloon and the flange 64 when the balloon isplaced in the EAC. The flange 64 can cover the orifice of the ear but isnot intended to completely seal the ear as the balloon is designed forsuch purpose further into the EAC. Referring to FIG. 6C, the module 60further includes an end cap 65. Thus, between the main housing 63 andend cap 65, the internal components of the module 60 are encased orplace within such area. FIG. 6D is a side view of the end cap 65 whichcan include dimples 67 defining a dimple boundary area. As can be moreclearly seen in FIG. 6E, the end cap can include a capacitive orresistive sensor 66 that enables a user to make predetermined gestureswith their figures to control one or more functions of the module 60 oran associated device communicatively and operationally coupled to themodule 60 (such as a cell phone). The dimples 67A and 67B provides auser a tactile registration as to where to place their fingers on theend cap 65 to appropriately make gestures using the sensor 66. The endcap 65 can also include an opening 68B that forms the beginning of anair or acoustic opening or vent that opens at 68A in FIG. 6B. Note, thevent is an optional feature or a feature that can be configured in manydifferent ways and not necessarily in the manner shown.

Because at least one portion of the module 60 may contact or penetratethe skin, the sensors and telemetric circuitry provide access to variousblood analytes through iontophoresis and electrochemical sensing thatmay not be easily be accessible by the other portions of the module 60.Additionally, the sensors in the module 60 may provide a good electricalcontact for ECG or skin conductivity.

FIGS. 7A and 7B illustrate yet another embodiment of a multifunctionalearpiece module 70 with right front perspective exploded views in shadedand black and white illustrated views respectively. The module 70 caninclude a balloon 71 that can carry one or more sensing devices. Theoval or ellipsoid shaped balloon 71 includes a central opening thatenables a stent or extension 72 of the main housing 73 to protrudethrough the central opening. The balloon can carry at least a first LED89A and optionally a second LED 89B used for pulse oximetry or bloodflow measurements. The balloon 71 can also include an adhesive oradhesive tape such as Gecko Tape 85 that will enable the balloon 71 toadhere better to the user's skin and yet allow easy removal uponparticular movement (e.g., torsion or twisting motion). The Gecko Tape85 can also be included on a stop flange 74 that would rest just outsidethe orifice of the ear once the module 70 is inserted and set in placewithin the EAC of the user. A thermometer 87 can be centrally disposedwithin balloon near the opening and within the stent or extension 72. Asshown in FIG. 2E, the main housing 73 of the module 70 of FIGS. 7A and7B can include a ventilation opening or channel 73A enabling air toenter through a hole (not shown) in a end cap 75 and through the channel73A to fill an area between the flange 74 and the balloon 71 while theballoon seals an area from the balloon 71 to the tympanic membrane (whenthe module 70 is appropriately placed within the user's EAC or earcanal. The end cap 75 encloses a number of components within the mainhousing 73 including a speaker housing 77 (having a speaker port 77A),an ear canal microphone 77B, a memory 83, a digital signal processor 86,a first ambient microphone 82A, a second ambient microphone 82B, an LED89 and a flex circuit 88 that couples the various electronic components.A portion 88A of the flex circuit can form an antenna for communicationsuch as Bluetooth. The DSP 86 can include other circuitry for wirelesscommunication processing as well. The flex circuit 88 can placed aroundthe speaker housing 77 (as shown) and also around a battery 78.

FIGS. 8A-C illustrate yet another monitoring device 80, according tosome embodiments, that can be integrated into a telemetric Bluetooth®module. Though a Bluetooth® module is illustrated as part of anapplication specific integrated circuit or ASIC 86, it should beunderstood that other telemetric modules can be used. Telemetric modulesaccording to some embodiments of the present invention may operate inopen architecture protocols, allowing multiple telemetric devices tocommunicate with each other. A Bluetooth® module (including themonitoring device) according to some embodiments herein can beintegrated into a wearable earpiece module (i.e., monitoring device 80described above). The monitoring device 80 illustrated in FIGS. 8A-Ccontain one or more sensors, and is operatively coupled to communicationmodule such as a Bluetooth® module. In one embodiments, the sensormodule or processing functions for sensors in some respect can beintegrated with the communication module or Bluetooth® module. Inanother embodiment, the sensor module is separated from the Bluetooth®module, and a cable or electrical wires can couple or connect betweenthe sensor module and the Bluetooth® module. For example, the sensorsthat may need to be exposed externally can be placed in the region nearor through the end cap 75 while sensors that may be better suited toreside within an enclosed area within the ear canal would be place nearor around the balloon. In some cases, contact leads or vias may connectbetween the sensor module and an extended sensor or an additional sensormodule. This allows the extended sensor or sensor module to be flexiblymounted anywhere inside, along, outside, or about the wearable sensormodule 80. Extended sensors can be especially useful for 4-pointgalvanometric monitoring of skin conductance, pulse oximetry, andvolatile organic compound monitoring.

Pulse oximetry is a standard noninvasive technique of estimating bloodgas levels. Pulse oximeters typically employ 2 or more opticalwavelengths to estimate the ratio of oxygenated to deoxygenated blood.Similarly, various types of hemoglobin, such as methemoglobin andcarboxyhemoglobin can be differentiated by measuring and comparing theoptical absorption at key red and near-infrared wavelengths. Additionalwavelengths can be incorporated and/or replace conventional wavelengths.For example, by adding additional visible and infrared wavelengths,myoglobin, methemoglobin, carboxyhemoglobin, bilirubin, SpCO2, and bloodurea nitrogen (BUN) can be estimated and/or monitored in real-time inaddition to the conventional pulse oximetry SpO2 measurement. The LED 89is placed on the balloon 71 for this purpose. The LED 89 can be amulti-wavelength LED or additional LEDs can be employed.

Referring to FIGS. 8A and 8B, the module 80 can include a number ofsensors on or near the balloon 71 such as a SAW or surface acoustic wavesensor 92, a non-invasive contactless sensor 93 (e.g., for EEG), an earcanal microphone 77B, and a thermometer 87A that can be used to sensephysiological activity within the confines of a sealed ear canal or EACsealed by the balloon 71. Other external sensors such as additionalthermometers and ambient microphones 82A and 82B can housed more towardsan external portion of a main housing 73. A stop flange 74 can be usedto provide further isolation and to prevent insertion of the (externalportion of the) module 80 beyond the orifice of the user's ear.Electronic components, electrical, acoustic and inflation lumens orchannels can be incorporated within the main housing 73 and an extensionor stent 72 of the main housing 73. The main housing 73 can also includean occlusion vent 97P (shown in FIG. 8C) that allows the pressure toequalize between the area defined between the balloon 71 and stop flange74 and the ambient environment.

FIG. 8C provides a further detailed illustration of the module 80 in theform of a right front perspective exploded view. In this embodiment, anear canal microphone 77B is brought to the centrally disposed opening ofthe balloon 71. A mesh 91 covers the microphone 77B to avoidcontaminants such as cerumen or ear wax from clogging the microphone. Asimilar mesh is also placed on ambient microphones 82A and 82B to avoidhaving dust or other particulars from the ambient environment clog upthe microphones 82A or 82B. As described above, the balloon 71 can carryor embed a number of sensors such as a SAW or surface acoustic wavesensor 92, a non-invasive contactless sensor 93 (e.g., for EEG), and LED89, and a thermometer 87A that can be used to sense physiologicalactivity within the confines of a sealed ear canal or EAC sealed by theballoon 71. The thermometer 87A can work in conjunction with an ambientthermal sensor 87B. Using a temperature differential betweenthermometers 87A and 87B can provide a more accurate measurement forcalories burned by a user. Additionally, the module 89 can include acapacitive gesture sensor 96 that can be placed on or embedded within anend cap 75.

The module 80 can include a number of channels or lumens that can bedefined by structures within a main housing 73 and a stent or extension72 of the main housing 73. A media or fluid conduit 71L can carry amedia such as a gas, fluid, or gel. The balloon 71 and fluid conduit 71Lis initially filled or pre-filled through an opening in the end cap 75and controlled using a dilation valve 81. When media is forced throughthe valve, the media is further forced through the conduit 71L andthrough a balloon or fluid port 71P in the stent 72 in order to inflateor fill the balloon 71 with the media. The module 80 further includesone or more acoustic conduits or lumens that enable acoustic sound totraverse such lumens. For example, an ear canal speaker lumen 77Lenables sound output by a speaker 77 and more particularly from aspeaker port 77A to traverse the lumen 77L to enable the end user tohear reproduced sound within a sealed EAC behind the balloon 71. Anotherlumen or acoustic channel 97L enables ambient acoustic sound to traversethe channel 97L. An electro active polymer (EAP) valve 97 can serve as acontrolling mechanism that controls the amount of ambient sound cantraverse the module 80. In this regard, the EAP valve 97 serves as an“aural iris” that opens and closes the ambient environment from theotherwise sealed area behind the balloon 71 (when appropriately placedin the user's EAC). The EAP valve 97 and channel 97L allows the tympanicmembrane to receive totally non-attenuated (non-electronically enhanced,passive) sound from the outside to the inside (within the sealed EAC) byusing the EAP to further modulate an external opening when it gets noisyby closing or reducing the size of such opening based on readings of theambient microphone(s). If the microphone hears no noise, then EAP valvecan be completely open. If a noisy environment is detected, then the EAPattenuates the port using the ambient microphone signal. Note that theEAP valve is silent since there is no motor and hence no motor movement.With no motor movement, the EAP provides silent operations in contrastto other valve mechanisms. An electrical port 99 can also have a lumenor channel to carry wiring through the module 80. For example, suchwiring can include wires from the ear canal microphone 77B orthermometer 87A to a flex circuit 98 or ASIC 86.

With respect to the “Aural Iris”, note that the embodiments are notnecessarily limited to using an EAP valve and that various embodimentswill generally revolve around five (5) different embodiments or aspects:

1. Pure attenuation for safety purposes. Rapid or quick response time bythe “iris” in the order of magnitude of 10s of milliseconds will helpprevent hearing loss (SPL damage) in cases of noise bursts. The responsetime of the iris device can be metered by knowing the noise reductionrating (NRR) of the balloon (or other occluding device being used). Theiris can help with various sources of noise induced hearing loss orNIHL. One source or cause of NIHL is the aforementioned noise burst.Unfortunately, bursts are not the only source or cause. A second sourceor cause of NIHL arises from a relatively constant level of noise over aperiod of time. Typically the level of noise causing NIHL is an SPLlevel over an OSHA prescribed level over a prescribed time.The iris can utilize its fast response time to lower the overallbackground noise exposure level for a user in a manner that can beimperceptible or transparent to the user. The actual SPL level canoscillate hundreds or thousands of times over the span of a day, but theiris can modulate the exposure levels to remain at or below theprescribed levels to avoid or mitigate NIHL.2. “Iris” used for habituation by self-adjusting to enable (hearing aid)user to acclimate over time or compensate occlusion effects.3. Iris enables power savings by changing duty cycle of when amplifiersand other energy consuming devices need to be on. By leaving theacoustical lumen in a passive (open) and natural state for the vastmajority of the time and only using active electronics in noisyenvironments (which presumably will be a smaller portion of mostpeople's day), then significant power savings can be realized in realworld applications. For example, in a hearing instrument, threecomponents generally consume a significant portion of the energyresources. The amplification that delivers the sound from the speaker tothe ear can consume 2 mWatts of power. A transceiver that offloadsprocessing and data from the hearing instrument to a phone (or otherportable device) and also receive such data can consume 12 mWatts ofpower or more. Furthermore, a processor that performs some of theprocessing before transmitting or after receiving data can also consumepower. The iris alleviates the amount of amplification, offloading, andprocessing being performed by such a hearing instrument.4. Iris preserves the overall pinnacues or authenticity of a signal. Asmore of an active listening mode is used (using an ambient microphone toport sound through an ear canal speaker), there is loss of authenticityof a signal due to FFTs, filter banks, amplifiers, etc causing a moreunnatural and synthetic sound. Note that phase issues will still likelyoccur due to the partial use of (natural) acoustics and partial use ofelectronic reproduction. This does not necessarily solve that issue, butjust provides an OVERALL preservation of pinnacues by enabling greateruse of natural acoustics. ????Two channels can be used5. Similar to #4 above . . . Iris also enables the preservation ofsituational awareness, particularly in the case of sharpshooters.Military believe they are “better off deaf than dead” and do not want tolose their ability to discriminate where sounds come from. When you plugboth ears you are compromising pinnacues. The Iris can overcome thisproblem by keeping the ear (acoustically) open and only shutting theiris when the gun is fired using a very fast response time. The responsetime would need to be in the order of magnitude of 5 to 10milliseconds??The acoustic iris can be embodied in various configurations orstructures with various alternative devices within the scope of theembodiments. In some embodiments, an aural iris 800 as shown in FIG. 8Dcan include a lumen 801 having a first opening 802 and a second opening803. The iris 800 can further include an actuator 804 coupled to or onthe first opening 802. In some embodiments as shown in FIG. 8E, an auraliris 810 can include the lumen 801 with actuators 804 and 805respectively coupled to or on or in both openings 802 or 803 of thelumen 801. In some embodiments as shown in FIG. 8F, an actuator 807 canbe placed in or at the opening 802 of the lumen 801. Preferably, the canbe made of flexible material such as elastomeric material to enable asnug and sealing fit to the opening as the actuator is actuated. Someembodiments can utilize a MEMs micro-actuator or micro-actuatorend-effector. In some embodiments, the actuators and the conduit or tubecan be several millimeters in cross-sectional diameter. The conduit orlumen will typically have an opening or opening area with a circular oroval edge and the actuator that would block or displace such opening oredges can serve to attenuate acoustic signals traveling down theacoustic conduit or lumen or tube. In some embodiments, the actuator cantake the form of a vertical displacement piston or moveable platformwith spherical plunger, flat plate or cone as shown in FIG. 8G. Furthernote that in the case of an earpiece, the lumen has two openingsincluding an opening to the ambient environment and an opening in theear canal facing towards the tympanic membrane. In some embodiments, theactuators are used on or in the ambient opening and in other embodimentsthe actuators are used on or in the internal opening. In yet otherembodiments, the actuators can be use on both openings. See FIGS. 8D,8E, and 8F referenced above.End effectors using a vertical displacement piston or moveable platformwith spherical plunger, flat plate or cone can require significantvertical travel (likely several hundred microns to a millimeter) totransition from fully open to fully closed position. The End-effectormay travel to and potentially contact the conduit edge without beingdamaged or sticking to conduit edge. Vertical alignment during assemblymay be a difficult task and may be yield-impacting during assembly orduring use in the field. In some preferred embodiments, the actuatorutilizes low-power with fast actuation stroke. Larger strokes implylonger (or slower) actuation times. A vertical displacement actuator mayinvolve a wider acoustic conduit around the actuator to allow sound topass around the actuator. Results may vary depending on whether theend-effector faces and actuates outwards towards the externalenvironment and the actual end-effector shape used in a particularapplication. Different shapes for the end-effector can impact acousticperformance.In some embodiments the end effector can take the form of a throttlevalve or tilt mirror as illustrated in FIG. 8H. In the “closed” positioneach of the tilt mirror members in an array of tilt mirrors would remainin a horizontal position. In an “open” position, at least one of thetilt mirror members would rotate or swivel around a single axis pivotpoint. Note that the throttle valve/tilt mirror design can take the formof a single tilt actuator in a grid array or use multiple (and likelysmaller) tilt actuators in a grid array. In some embodiments, all thetilt actuators in a grid array would remain horizontal in a “closed”position while in an “open” position all (or some) of the tilt actuatorsin the grid array would tilt or rotate from the horizontal position asshown in FIG. 8I.Throttle Valve/Tilt-Mirror (TVTM) configurations can be simpler indesign since they are planar structures that do not necessarily need toseal to a conduit edge like vertical displacement actuators. Also, asingle axis tilt can be sufficient. Use of TVTM structures can avoidacoustic re-routing (wide by-pass conduit) as might be used withvertical displacement actuators. Furthermore, it is likely that TVTMconfigurations have smaller/faster actuation than vertical displacementactuators and likely a correspondingly lower power usage than verticaldisplacement actuators.In yet other embodiments, a micro acoustic iris end-effector can takethe form of a tunable grating having multiple displacement actuators ina grid array as shown in FIG. 8J. In a closed position, all actuatorsare horizontally aligned. In an open position, one or more of thetunable grating actuators in the grid array would be verticallydisplaced. As with the TVTM configurations, the tunable gratingconfigurations can be simpler in design since they are planar structuresthat do not necessarily need to seal to a conduit edge like verticaldisplacement actuators. Use of tunable grating structures can also avoidacoustic re-routing (wide by-pass conduit) as might be used withvertical displacement actuators. Furthermore, it is likely that tunablegrating configurations have smaller/faster actuation than verticaldisplacement actuators and likely a correspondingly lower power usagethan vertical displacement actuators.In yet other embodiments, a micro acoustic iris end-effector can takethe form of a horizontal displacement plate having multiple displacementactuators in a grid array as shown in FIG. 8K. In a closed position, allactuators are horizontally aligned in an overlapping fashion to seal anopening. In an open position, one or more of the displacement actuatorsin the grid array would be horizontally displaced leaving one or moreopenings for acoustic transmissions. As with the TVTM configurations,the horizontal displacement configurations can be simpler in designsince they are planar structures that do not necessarily need to seal toa conduit edge like vertical displacement actuators. Use of horizontaldisplacement plate structures can also avoid acoustic re-routing (wideby-pass conduit) as might be used with vertical displacement actuators.Furthermore, it is likely that horizontal displacement plateconfigurations have smaller/faster actuation than vertical displacementactuators and likely a correspondingly lower power usage than verticaldisplacement actuators.In some embodiments, a micro acoustic iris end-effector can take theform of a zipping or curling actuator as shown in FIG. 8L. In a closedposition, the zipping or curling actuator member lies flat andhorizontally aligned in an overlapping fashion to seal an opening. In anopen position, zipping or curling actuator curls away leaving an openingfor acoustic transmissions. The zipping or curling embodiments can bedesigned as a single actuator or multiple actuators in a grid array.FIG. 8M illustrates an example of a MEMS electrostatic zipping actuatorin an open position with the actuators curled up. As with the TVTMconfigurations, the displacement configurations can be simpler in designsince they are planar structures that do not necessarily need to seal toa conduit edge like vertical displacement actuators. Use of horizontalcurling or zipping structures can also avoid acoustic re-routing (wideby-pass conduit) as might be used with vertical displacement actuators.Furthermore, it is likely that curling or zipping configurations havesmaller/faster actuation than vertical displacement actuators and likelya correspondingly lower power usage than vertical displacementactuators.In some embodiments, a micro acoustic iris end-effector can take theform of a rotary vane actuator as shown in FIG. 8N. In a closedposition, the rotary vane actuator member covers one or more openings toseal such openings. In an open position, rotary vane actuator rotatesand leaves one or more openings exposed for acoustic transmissions. Aswith the TVTM configurations, the rotary vane configurations can besimpler in design since they are planar structures that do notnecessarily need to seal to a conduit edge like vertical displacementactuators. Use of rotary vane structures can also avoid acousticre-routing (wide by-pass conduit) as might be used with verticaldisplacement actuators. Furthermore, it is likely that rotary vaneconfigurations have smaller/faster actuation than vertical displacementactuators and likely a correspondingly lower power usage than verticaldisplacement actuators.In yet other embodiments, the micro-acoustic iris end effectors can bemade of acoustic meta-materials and structures. Such meta-materials andstructures can be activated to dampen acoustic signals.Note that the embodiments are not limited to the aforementionedmicro-actuator types, but can include other micro or macro actuatortypes (depending on the application) including, but not limited tomagnetostrictive, piezoelectric, electromagnetic, electoactive polymer,pneumatic, hydraulic, thermal biomorph, state change, SMA, parallelplate, piezoelectric biomorph, electrostatic relay, curved electrode,repulsive force, solid expansion, comb drive, magnetic relay,piezoelectric expansion, external field, thermal relay, topologyoptimized, S-shaped actuator, distributed actuator, inchworm, fluidexpansion, scratch drive, or impact actuator.Although there are numerous modes of actuation, the modes of mostpromise for an acoustic iris application in an earpiece or othercommunication or hearing device can include piezoelectricmicro-actuators and electrostatic micro-actuators.Piezoelectric micro-actuators cause motion by piezoelectric materialstrain induced by an electric field. Piezoelectric micro-actuatorsfeature low power consumption and fast actuation speeds in themicro-second through tens of microsecond range. Energy density ismoderate to high. Actuation distance can be moderate or (more typically)low. Actuation voltage increases with actuation stroke andrestoring-force structure spring constant. Voltage step-up ApplicationSpecific Integrated Circuits or ASICs can be used in conjunction withthe actuator to provide necessary actuation voltages.

Motion can be horizontal or vertical. Actuation displacement can beamplified by using embedded lever arms/plates. Industrial actuator andsensor applications include resonators, microfluidic pumps and valves,inkjet printheads, microphones, energy harvesters, etc.. Piezo-actuatorsrequire the deposition and pattern etching of piezoelectric thin filmssuch as PZT (lead zirconate titanate with high piezo coefficients) orAlN (aluminum nitride with moderate piezo coefficients) with specificdeposited crystalline orientation.

One example is a MEMS microvalve or micropump. The working principle isa volumetric membrane pump, with a pair of check valves, integrated in aMEMS chip with a sub-micron precision. The chip can be a stack of 3layers bonded together: a silicon on insulator (SOI) plate withmicro-machined pump-structures and two silicon cover plates withthrough-holes. This MEMS chip arrangement is assembled with apiezoelectric actuator that moves the membrane in a reciprocatingmovement to compress and decompress the fluid in the pumping chamber.Electrostatic micro-actuators induce motion by attraction betweenoppositely charged conductors. Electrostatic micro-actuators feature lowpower consumption and fast actuation speeds in the micro-second throughtens of microsecond range. Energy density is moderate. Actuationdistance can be high or low, but actuation voltage increases withactuation stroke and restoring-force structure spring constant.Often-times, charge-pumps or other on-chip or adjacent chip voltagestep-up ASIC's are used in conjunction with the actuator, to providenecessary actuation voltages. Motion can be horizontal, vertical, rotaryor compound direction (tilting, zipping, inch-worm, scratch, etc.).Industrial actuator and sensor applications include resonators, opticaland RF switches, MEMS display devices, optical scanners, cell phonecamera auto-focus modules and microphones, tunable optical gratings,adaptive optics, inertial sensors, microfluidic pumps, etc.. Devices canbe built using semi-conductor or custom micro-electronic materials. Mostvolume MEMS devices are electrostatic.One example of a MEMS electrostatic actuator is a linear comb drive thatincludes a polysilicon resonator fabricated using a surfacemicromachining process as shown in FIG. 8O. Another example is the MEMselectrostatic zipping actuator shown in FIG. 8M. Yet another example ofa MEMS electrostatic actuator is a MEMS tilt mirror which can a singleaxis or dual axis tilt mirror. Examples of tilt mirrors include TexasInstruments Digital Micro-mirror Device (DMD), the Lucent Technologiesoptical switch micro mirror, and the Innoluce MEMS mirror among others.Some existing MEMS micro-actuator devices that could potentially bemodified for use in an acoustic iris as discussed above include:

-   -   Invensas low power vertical displacement electrostatic        micro-actuator MEMS auto-focus device, using lens or later        custom modified shape end-effector. (Piston Micro Acoustic Iris)    -   Innoluce or Precisely Microtechnology single-axis MEMS tilt        mirror electrostatic micro-actuator. (Throttle Valve Micro        Acoustic Iris)        More of a stretch    -   Wavelens electrostatic MEMS fluidic lens plate micro-actuator.        (Piston Micro Acoustic Iris)    -   Debiotech piezo MEMS micro-actuator valve. (Vertical Valve Micro        Acoustic Iris)    -   Boston Micromachines—electrostatic adaptive optics module custom        modified for tunable grating applications. (Tunable Grating        Micro Acoustic Iris)        Yet more of a stretch . . . and investment . . .    -   Silex Microsystems or Innovative MicroTechnologies (IMT) MEMS        foundries—custom rotary electrostatic comb actuator or motor        build in SOI silicon. (Rotary Vane Micro Acoustic Iris)

The components within the main housing 73 primarily includes the speaker77, a battery 78, a memory 83, LED 89, ambient microphones 82A, 82B, theASIC 86, and the flex circuit 98 that couples the various components.The flex circuit 98 can include an integrated antenna or micro antenna88 used for communication with other devices. Between the battery 78 andthe end cap 75 can reside a inductive charging coil 94 and optionally asolar cell 95 used for further charging the battery 78 or independentlyor mutually powering other devices or components within the module 80.The end cap 75 can be made of a clear or transparent material such as aclear plastic to allow light energy to be absorbed by the solar cell 95.In one embodiment, the solar cell 95 is used to trickle charge thebattery 78 when the solar cell is exposed to light (whether the module80 is within the ear or not).

The embodiments described above are not limited to using orincorporating the sensors described therein. Different sensors can besubstituted or existing sensors can be used for different purposes.Blood hydration can also be monitored optically, as water selectivelyabsorbs optical wavelengths in the mid-IR and blue-UV ranges, whereaswater can be more transparent to the blue-green wavelengths. Thus, thesame optical emitter/detector configuration used in earpiece pulseoximetry can be employed for hydration monitoring. However, mid-IR orblue optical emitters and detectors may be required. Additionally,monitoring the ratio of blue-green to other transmitted or reflectedwavelengths may aid the real-time assessment of blood hydration levels.Blood hydration can also be monitored by measuring changes incapacitance, resistance, or inductance along the ear in response tovarying water-content in the skin tissues or blood. Similarly, hydrationcan be estimated by monitoring ions extracted via iontophoresis acrossthe skin. Additionally, measuring the return velocity of reflected sound(including ultrasound) entering the head can be used to gauge hydration.These hydration sensors can be mounted anywhere within or along anearpiece or other monitoring device 80. It should be noted that otherhydration sensors can also be incorporated into a module.

A variety of techniques can be used for monitoring blood metabolites viaan earpiece module, such as wearable monitoring device 80. For example,glucose can be monitored via iontophoresis at the surface of the skincombined with enzyme detection. Blood urea nitrogen (BUN) can bemonitored by monitoring UV fluorescence in blood (through the skin) orby monitoring visible and mid-IR light absorption using the pulseoximetry approach described above. Various ions such as sodium,potassium, magnesium, calcium, iron, copper, nickel, and other metalions, can be monitored via selective electrodes in an earpiece modulefollowing iontophoresis through the skin.

Cardiopulmonary functioning can be evaluated by monitoring bloodpressure, pulse, cardiac output, and blood gas levels via earpiecemodules, and other monitoring apparatus in accordance with someembodiments herein. Pulse rate and intensity can be monitored throughpulse oximetry (described above) as well as by sensing an increase inoxygenated blood with time. Pulse rate and blood flow may also beassessed through impedance measurements via galvanometry near a bloodvessel. Additionally, pulse rate and blood flow may be assessed througha fast-response thermal energy sensor, such as a pyroelectric sensor.Because moving blood may temporarily increase or decrease the localizedtemperature near a blood vessel, a pyroelectric sensor will generate anelectrical signal that is proportional to the total blood flow in time.

Blood pressure can be monitored within the ear canal, for example.According to some embodiments, a digital blood pressure meter isintegrated into an earpiece module, such as earpiece 80 of FIG. 8C.Actuators and sonic and pressure transducers can be placed along the earcanal (or earlobe), and systolic and diastolic pressure can be measuredby monitoring the pressure at which the well-known Korotkoff sound isfirst heard (systolic), then disappears (diastolic). This technique canalso be used to monitor intra-cranial pressure and other internalpressures. Blood pressure may also be measured by comparing the timebetween pulses at different regions of the body. For example, sensorsfor monitoring pulse rate and blood volume can be located in front ofthe ear and behind the ear or at the earlobe, and the time between thedetection of each pulse from each sensor, as well as the volume of bloodpassed, can be processed by a signal processor 86 into an indication ofblood pressure.

Electrodes within or about an earpiece can also be utilized to monitorblood gases diffused through the skin, giving an indication of blood gasmetabolism. For example, a compact Severinghaus electrode can beincorporated within an earpiece module for the real-time monitoring ofCO2 levels in the blood, for example, through an earlobe connector, asensor region of an earpiece fitting, or along or about an ear support.These Severinghaus-type electrodes can also be used to monitor otherblood gases besides CO2, such as oxygen and nitrogen.

Organ function monitoring includes monitoring, for example, the liver,kidneys, pancreas, skin, and other vital or important organs. Liverquality can be monitored noninvasively by monitoring optical absorptionand reflection at various optical wavelengths. For example, opticalreflection from white LEDs or selected visible-wavelength LEDs can beused to monitor bilirubin levels in the skin and blood, for a real-timeassessment of liver health.

Monitoring neurological functioning can be accomplished via electrodesor via non-invasive contactless sensors placed at the ear, near the ear,or within the walls of the ear canal and particularly closer to theskull. When such electrodes are placed along the forehead, this processis described as electroencephalography, and the resulting data is calledan electroencephalogram (EEG). These electrodes can be either integratedinto an earpiece module or connected to an earpiece module, according tosome embodiments of the present invention. For example, the balloon 71can be modified to conform with EEG electrodes or other electrodes formeasuring brain waves or neurological activity. For monitoringneurological functioning, a temple earpiece may also be used. Electrodesmay be positioned in a temple earpiece region near the temples of a userfor direct contact with the skin. In some embodiments, direct contact isnot necessary, and the neurological functioning can be monitoredcapacitively, inductively, electromagnetically, or a combination ofthese approaches as is the case when the sensors 92 shown in FIG. 8C areembedded or placed within the balloon 71. In some embodiments, brainwaves may couple with low frequency acoustical sensors integrated intoan earpiece module.

In some embodiments, neurological functioning can be monitored usingelectrodes that are placed in the ear and more particularly within theexternal auditory canal (EAC). In one embodiment, the one or moreelectrodes can be embedded on or within a expandable element or balloonthat forms part of an earpiece. The electrodes will have access to astable and secure location that is at least as close to the skull asconventional EEG electrodes used on the surface of one's head.

In some embodiments, the electrodes used in an earpiece can usemultimodal electrodes that monitor or measure various parameters. Forexample, the electrode can be used to monitor one or more of brainactivity (EEG), cardiac activity (ECG), muscular activity (EMG), skinconductivity, breathing, or speech. The multimodal electrode can be usedfor concurrent and co-located electrical and mechanical signalacquisition. Such multimodal embodiment can by used in variousapplications including, but not limited to, physical and mental statemonitoring in medicine, sports, military, research, entertainment, orbiological studies. For example, such a device can form part of acardiovascular monitoring system for disease diagnosis or of a stressand fatigue monitoring system for soldiers, performers, or athletes. Insome chronic diseases, the EEG can make long term recordings to monitorand track patients with epilepsy or other diseases. The device can alsobe used for human and animal biomechanics research. Such a system can beultra-low power, light weight, unobstrusive, and exhibiting lowelectrical impedance which helps achieve low noise, high qualityelectrical readings, particularly in low signal power scenarios such asEEG. The electrical and mechanical sensing can be decoupled and yetco-located. Such a system can be manufactured at a low cost and be madedisposable. The balloon 71, as mentioned previously, enables andfacilitates a stable ecosystem to acquire such sensor data with minimalor no corruption or motion artifacts to the extent that algorithms forremoving such motion artifacts become unnecessary.

In some embodiments, the EEG electrodes within the EAC can be used tomonitor or measure a level of sleep quality. In other aspects, the EEGcan be used to monitor apnea-induced hypoxemia or sleep apnea basedmeasurements of electrocortical activity. Sleep apnea is a potentiallyserious sleep disorder in which breathing repeatedly stops and starts.Sleep apnea is sometimes diagnosed if one snores loudly and they feeltired even after a full night's sleep. Although snoring is notdefinitive, it is considered a soft marker of the condition. There aretwo main types of sleep apnea. One type is known as Obstructive sleepapnea which is the more common form that occurs when throat musclesrelax. The second type is Central sleep apnea, which occurs when yourbrain doesn't send proper signals to the muscles that control breathing.Treatment is necessary to avoid heart problems and other complications.

In some embodiments, an earpiece device can be used to monitorindividuals with obstructive sleep apnea syndrome (OSAS). The EEGrecordings can be timed with respiratory events or other monitoredvitals. In some embodiments, the earpiece device can be used to monitorREM or non-REM sleep which is used in diagnosing sleep apnea. Theearpiece device can further monitor other aspects for furthercorrelation or correspondence to suspected disorders. For example, amicrophone or other transducer can monitor for sounds such as snoring oranother sensor can monitor for restlessness or other motion. Thus, asingle earpiece device (or a combination in a pair of earpieces) canserve to detect various diseases, disorders, or conditions by monitoringEEG that looks at neurological data in combination with other datagathered from sound or motion detectors or sensors. If a particularprofile of sensing data meets a threshold indicative of one condition oranother, the device can further include a reporting mechanism thatprovides notice (and optionally the actual data) to an appropriatephysician such as a pulmonologist, neurologist or internist. Furthernote that in some embodiments, the physical profile monitoring device inthe form of an earpiece should not extending from the concha bowl toavoid dislodging by a pillow or other movement during sleep or restsince minimal or no physical contact should be made with the earpieceduring such analysis.

In some embodiments, by using the ear as the location for electrodes (ina wireless earpiece) used in electroencephalography (EEG), a patient orphysician can avoid having to shave a patient's scalp and further avoidattaching many electrodes and cables. With sufficient battery life, thedevice can be used to monitor patients over extended periods of time andenable monitoring of patients having regularly recurring problems suchas seizures or microsleep. The placement of the EEG electrodes insidethe EAC makes for a stable and consistent recording system that issubstantially free of signal noise due to body movement. Such signalnoise can further be detected and filtered as discussed elsewhereherein. Using the ear also ensures that the electrodes are essentiallyplaced in the same spot providing for greater consistency andreliability between different readings. The balloon or expandableelement in the earpiece further adds to the stability and consistency ofthe recording environment. The balloon when placed appropriately,essentially registers with the ear's anatomy and locks in place.Furthermore, the balloon provides the added isolation from ambient noisethat other devices fail to provide when using microphones as part of anoverall sensing scheme.

In some embodiments, the monitoring of EEG and/or one or more otherphysiological parameter can assist in the assessment or treatment oranalysis of one or more of behavior studies, estimation of auditoryattention (feedback to hearing aids), fatigue monitoring, vigilance oralertness monitoring, hypoglycemia, Alzheimer's, Dementia,Schizophrenia, Neurodegenerative diseases, Epilepsies, Brain ComputerInterface (BCI), Sleep monitoring, Objective Hearing Threshold (HTL)estimation, antidepressants, Parkinson disease, Attention DeficitHyperactivity Disorder (ADHD), Stress monitoring, or objectiveassessment or monitoring of the effect and efficacy of treatment orrehabilitation. Note that the HTL estimation can be used for the fittingof hearing aids or for tracking a hear loss characteristic. The BCI canbe used as a user interface enabling conscious and unconscious control.In one example, using the modules herein as a fatigue monitor can enablea user to monitor neurological changes and can provide feedback in theform of a sound, haptic output, shock, etc. in order to stimulate orwake up someone who may be getting drowsy during a long drive. Inanother example, the monitoring device operating as a hypoglycemicmonitor can monitor high or low blood sugar levels and provide anacoustic stimuli regarding such status to enable the user to takecorrective action.

In some embodiments, the expandable element or balloon and optionallythe flange can include adhesive skin such as Gecko Tape or GeckSkin™(developed by the University of Massachusetts at Amherst) on the outersurface of the expandable element or flange to enable the expandableelement, balloon, or flange to adequately grasp or attach to the user'sskin. GeckSkin uses draping adhesion inspired by toe pads of geckos.GeckSkin allows for a rapid and low-energy transition between attachmentand detachment

A person's body motion and head position can also be monitored byintegrating a motion sensor into an earpiece module. Two such compactmotion sensors include gyroscopes and accelerometers, typicallymechanical or optical in origin. In some embodiments, an accelerometermay be composed of one or more microelectromechanical systems (MEMS)devices. In some embodiments, an accelerometer can measure accelerationor position in 2 or more axes. When the head is moved, a motion sensordetects the displaced motion from the origin. A head position monitorcan be used to sense convulsions or seizures and relay this informationwirelessly to a recording device. Similarly, head position monitoringmay serve as a feedback mechanism for exercise and athletic trainingwhere head positioning with respect to the body is important.Additionally, the head position monitoring can be used to monitor whensomeone has fallen down or is not moving. The monitoring of body motionor head position can also be used to activate functions on the module 80or other devices operational coupled to the module 80. Further note thatthe accelerometers or other motion detectors can also be used as part ofa Voice Activity Detector or VAD. In some embodiments, detection of afall can be based on the measurements made by an accelerometer (and thedirection of the movement). Such a system could provide a user withaccess to emergency services and further provide feedback (acoustic) tothe user.

Body temperature, including core and skin temperature, can be monitoredin real-time by integrating compact infrared sensors into an earpiecemodule, according to some embodiments of the present invention. Infraredsensors are generally composed of thermoelectric/pyroelectric materialsor semiconductor devices, such as photodiodes or photoconductors.Thermistors, thermocouples, and other temperature-dependent transducerscan also be incorporated for monitoring body temperature. These sensorscan be very compact and thus can be integrated throughout an earpiecemodule. In some embodiments, these sensors may be mounted along thebackside of an earpiece body where the earpiece connects with the earcanal. Temperature sensors aimed at the tympanic membrane may be moreaccurate than sensors aimed in other directions. A combination oftemperature sensors and use of temperature differentials can alsoprovide more accurate readings and significant or useful data.

In some embodiments, a pedometer can be integrated into an earpiecemodule to measure the number of steps walked during a day. Pedometersthat can be integrated into an earpiece module include, but are notlimited to, mechanical pedometers (usually implementing a metallic ballor spring), microelectromechanical systems (MEMS) pedometers, inertialsensor pedometers, accelerometer-based pedometers, accelerometry,gyroscopic pedometers, and the like.

In some embodiments, a pedometer for an earpiece module employs anacoustic sensor for monitoring the characteristic sounds of footstepschanneled along the ear canal. For example, an acoustic sensor can beintegrated into an earpiece housing along the backside thereof and/orwithin an earpiece fitting thereof. The sounds generated from footstepscan be detected and analyzed with a signal processor using a noisecancellation or signal extraction approach to identify footstep soundsin the midst of convoluting physiological noise. In this embodiment,digitized electrical signals from footstep sounds from outside the bodyare compared with digitized electrical signals from footstep soundstraveling through the body (and ear canal), and only the spectralfeatures associated with both types of digitized signals are amplified.This provides a new signal that contains cleaner information aboutfootsteps.

Breathing characteristics can also be monitored in a manner similar tothat of acoustic pedometry (described above) via auscultatory signalextraction. In some embodiments, an acoustic sensor in an earpiecemodule is used to sense sounds associated with breathing. Signalprocessing algorithms are then used to extract breathing sounds fromother sounds and noise. This information is processed into a breathingmonitor, capable of monitoring, for example, the intensity, volume, andspeed of breathing. Another method of monitoring breathing is to employpressure transducers into an earpiece module. Changes in pressure insideor near the ear associated with breathing can be measured directly and,through signal processing, translated into a breathing monitor.Similarly, optical reflection sensors can be used to monitor pressure inor near the ear by monitoring physical changes in the skin or tissues inresponse to breathing. For monitoring the physical changes of thetympanic membrane in response to breathing, and hence ascertainingbreathing rate, an optical signal extraction approach may be employed.At least one color sensor, or colorimetric sensor, can be employed tomonitor changes in color associated with breathing and other healthfactors.

It should be noted that some embodiments of the present inventionincorporate health sensors that do not employ chemical or biologicalreagents for monitoring various health factors. This is because suchsensors have traditionally required larger instrumentation (not suitablefor portability) and/or disposable samplers (not acceptable to most endusers). However, sensors employing chemical or biological reagents maybe incorporated into earpiece modules, according to some embodiments.For example, the diffusion of analyte through the skin can be monitoredelectrically or optically by selective binding to enzymes or antibodiescontained in the health sensors integrated into an earpiece module. Insome cases, iontophoresis, agitation, heat, or osmosis may be requiredto pull ions from the skin or blood into the sensor region formonitoring health factors. In some cases, these analytes may be taggedwith markers for electromagnetic, electrical, nuclear, or magneticdetection.

Caloric intake, physical activity, and metabolism can be monitored usinga core temperature sensor, an accelerometer, a sound extractionmethodology, a pulse oximeter, a hydration sensor, and the like. Thesesensors can be used individually or in unison to assess overall caloricmetabolism and physical activity for purposes such as diet monitoring,exercise monitoring, athletic training, and the like. For example, asound extraction methodology can be used to extract sounds associatedwith swallowing, and this can give an indication of total food volumeconsumed. Additionally, a core temperature sensor, such as a thermopile,a pyroelectric sensor, a thermoelectric sensor, or a thermistor, or atympanic membrane extraction technique, can be used to assessmetabolism. In one case, the core temperature is compared with theoutdoor temperature, and an estimate of the heat loss from the body ismade, which is related to metabolism.

Environmental temperature can be monitored, for example, by thermistor,thermocouple, diode junction drop reference, or the like. Electricaltemperature measurement techniques are well known to those skilled inthe art, and are of suitable size and power consumption that they can beintegrated into a wireless earpiece module without significant impact onthe size or functionality of the wireless earpiece module.

Environmental noise can be monitored, for example, by transducer,microphone, or the like. Monitoring of environmental noise preferablyincludes, but is not limited to, instantaneous intensity, spectralfrequency, repetition frequency, peak intensity, commonly in units ofdecibels, and cumulative noise level exposures, commonly in units ofdecibel-hours. This environmental noise may or may not include noisegenerated by a person wearing an earpiece module. Sound made by a personwearing an earpiece module may be filtered out, for example, usinganalog or digital noise cancellation techniques, by directionalmicrophone head shaping, or the like. The environmental noise sensor mayor may not be the same sensor as that used for the intended purpose ofwireless communication. In some embodiments, the environmental noisesensor is a separate sensor having broader audible detection range ofnoise level and frequency, at the possible sacrifice of audio quality.

Environmental smog includes VOC's, formaldehyde, alkenes, nitric oxide,PAH's, sulfur dioxide, carbon monoxide, olefins, aromatic compounds,xylene compounds, and the like. Monitoring of the aforementioned smogcomponents can be performed using earpiece modules and other wearableapparatus, according to some embodiments of the present invention, andin a variety of methods. All smog components may be monitored.Alternatively, single smog components or combinations of smog componentsmay be monitored. Photoionization detectors (PID's) may be used toprovide continuous monitoring and instantaneous readings. Other methodsof detecting smog components according to embodiments of the presentinvention include, but are not limited to, electrocatalytic,photocatalytic, photoelectrocatalytic, calorimetric, spectroscopic orchemical reaction methods. Examples of monitoring techniques using theaforementioned methods may include, but are not limited to, IR laserabsorption spectroscopy, difference frequency generation laserspectroscopy, porous silicon optical microcavities, surface plasmonresonance, absorptive polymers, absorptive dielectrics, and calorimetricsensors. For example, absorptive polymer capacitors inductors, or otherabsorptive polymer-based electronics can be incorporated into anearpiece module (e.g., 5 or 5A, FIG. 1) according to embodiments. Thesepolymers change size or electrical or optical properties in response toanalyte(s) from the environment (such as those described above). Theelectrical signal from these absorptive polymer electronic sensors canbe correlated with the type and intensity of environmental analyte.Other techniques or combinations of techniques may also be employed tomonitor smog components. For example, a smog component may be monitoredin addition to a reference, such as oxygen, nitrogen, hydrogen, or thelike. Simultaneous monitoring of smog components with a referenceanalyte of known concentration allows for calibration of the estimatedconcentration of the smog component with respect to the referenceanalyte within the vicinity of an earpiece user.

In some embodiments, environmental air particles can be monitored with aflow cell and a particle counter, particle sizer, particle identifier,or other particulate matter sensor incorporated as part of an earpiecemodule or externally attached to an earpiece module. Non-limitingexamples of particles include oil, metal shavings, dust, smoke, ash,mold, or other biological contaminates such as pollen. In someembodiments of the present invention, a sensor for monitoring particlesize and concentration is an optical particle counter. A light source isused (e.g., a laser or a laser diode), to illuminate a stream of airflow. However, a directional LED beam, generated by a resonant cavityLED (RCLED), a specially lensed LED, or an intense LED point source, canalso be used for particle detection. The optical detector which isoff-axis from the light beam measures the amount of light scattered froma single particle by refraction and diffraction. Both the size and thenumber of particles can be measured at the same time. The size of themonitored particle is estimated by the intensity of the scattered light.Additionally, particles can be detected by ionization detection, as witha commercial ionization smoke detector. In this case, a low-levelnuclear radiation source, such as americium-241, may be used to ionizeparticles in the air between two electrodes, and the total ionizedcharge is detected between the electrodes. As a further example,piezoelectric crystals and piezoelectric resonator devices can be usedto monitor particles in that particles reaching the piezoelectricsurface change the mass and hence frequency of electromechanicalresonance, and this can be correlated with particle mass. If theresonators are coated with selective coatings, certain types ofparticles can attach preferentially to the resonator, facilitating theidentification of certain types of particles in the air near a personwearing an earpiece module. In some embodiments, these resonators aresolid state electrical devices, such as MEMS devices, thin film bulkacoustic resonators (FBARs), surface-acoustic wave (SAW) devices, or thelike. These compact solid state components may be arrayed, each arrayedelement having a different selective coating, for monitoring varioustypes of particles. To the extent that the sensors can be mounted orembedded on or within an expandable element or balloon, the additionalisolation provided by such balloon, particularly isolation within theEAC, only serves to provide for a more efficient and elegant solution toother solutions that include corrupted data or must be compensated forsuch corrupted data.

In some embodiments of the present invention, environmental air pressureor barometric pressure can be monitored by a barometer. Non-limitingexamples of barometric pressure measurement include hydrostatic columnsusing mercury, water, or the like, foil-based or semiconductor-basedstrain gauge, pressure transducers, or the like. In some embodiments ofthe present invention, semiconductor-based strain gauges are utilized. Astrain gauge may utilize a piezoresistive material that gives anelectrical response that is indicative of the amount of deflection orstrain due to atmospheric pressure. Atmospheric pressure shows a diurnalcycle caused by global atmospheric tides. Environmental atmosphericpressure is of interest for prediction of weather and climate changes.Environmental pressure may also be used in conjunction with othersensing elements, such as temperature and humidity to calculate otherenvironmental factors, such as dew point. Air pressure can also bemeasured by a compact MEMS device composed of a microscale diaphragm,where the diaphragm is displaced under differential pressure and thisstrain is monitored by the piezoelectric or piezoresistive effect.

In some embodiments of the present invention, environmental humidity,relative humidity, and dew point can be monitored by measuringcapacitance, resistivity or thermal conductivity of materials exposed tothe air, or by spectroscopy changes in the air itself. Resistivehumidity sensors measure the change in electrical impedance of ahygroscopic medium such as a conductive polymer, salt, or treatedsubstrate. Capacitive humidity sensors utilize incremental change in thedielectric constant of a dielectric, which is nearly directlyproportional to the relative humidity of the surrounding environment.Thermal humidity sensors measure the absolute humidity by quantifyingthe difference between the thermal conductivity of dry air and that ofair containing water vapor. Humidity data can be stored along withpressure monitor data, and a simple algorithm can be used to extrapolatethe dew point. In some embodiments of the present invention, monitoringhumidity is performed via spectroscopy. The absorption of light by watermolecules in air is well known to those skilled in the art. The amountof absorption at known wavelengths is indicative of the humidity orrelative humidity. Humidity may be monitored with a spectroscopic methodthat is compatible with the smog monitoring spectroscopic methoddescribed above.

When environmental factors such as the aforementioned are monitoredcontinuously in real-time, a user's total exposure level to anenvironmental factor can be recorded. When a representative volume ofair a user has been exposed to is monitored or estimated, the volumetricconcentration of the analytes can be calculated or estimated. In orderto estimate the volume of air a person wearing an earpiece has beenexposed to, a pedometer or accelerometer or air flow sensor can also beintegrated into an earpiece module. Pedometers and accelerometers can beintegrated into an earpiece module via mechanical sensors (usuallyimplementing a mechanical-electrical switch), MEMS devices, and/orgyroscopic technologies. The technologies required for these types ofpedometers and accelerators are well known to those skilled in the art.The incorporated pedometer or accelerometer (or more than one pedometeror accelerometer) is used to gage the distance a person has traveled,for use in the estimation of the volume of air to which a person hasbeen exposed, and the subsequent estimate of the volumetricconcentration of monitored analytes.

The health and environmental sensors utilized with earpiece modules andother wearable monitoring apparatus, according to embodiments of thepresent invention, can operate through a user-selectable switch on anearpiece module. However, health and environmental sensors can also berun automatically and independently of the person wearing the apparatus.In other embodiments, the person may control health and environmentalmonitoring through a device wirelessly coupled to an earpiece module,such as a portable telecommunication device. For example, health andenvironmental sensors in or about an earpiece module can be controlledwirelessly through, for example, a cell phone, laptop, or personaldigital assistant (PDA).

FIG. 9 illustrates a graphical user interface for displaying data,according to some embodiments. A display on a device communicativelycoupled to any one of the monitoring devices (1, 20, 40, 60, 70, or 80)can show various biometric, environmental, neurological or otherparameter can be tracked. A user can track their own data or withappropriate permissions can track and compare their data with others.Such information can be displayed on a cellular phone, computer, orother output device. Anonymized data from particular demographic groupscan also be used to compare with personalized data. Such information canbe in a number of ways including medical analysis, health and fitnesstracking, and for competition. The data is generally real time or nearreal time data and can be selected or customized by the user or a careprovider or fitness trainer to provide pertinent data. FIG. 12illustrates a system that includes the monitoring module 80, a cellularphone 6D operatively coupled to the module 80 and a user interface orscreen 121 of the cellular phone illustrating some sample vital signsand environmental statistics that is captured either by the monitoringmodule 80, the cellular phone 6D or both. For example, if locationinformation or altitude information is obtainable from a GPS module inthe cell phone 6D, then such information can be used in conjunction withother sensor information captured by the monitoring module 80.

A wearable monitoring device may be configured such that userpreferences can be “downloaded” wirelessly without requiring changes tothe earpiece monitor hardware. For example, an earpiece concerned abouta heart condition may wish to have the signal processor 4 (of FIG. IA)focus on processing pulse signature, at the expense of ignoring otherphysiological or environmental parameters. The user may then use aportable telecommunication device to download a specialized algorithmthrough the web. This may be accomplished through existing wirelessinfrastructure by text-messaging to a database containing the algorithm.The user will then have an earpiece module suited with analysis softwarespecialized to the needs and desires of the user.

Health and environmental monitors, according to embodiments of thepresent invention, enable low-cost, real-time personal health andenvironmental exposure assessment monitoring of various health factors.An individual's health and environmental exposure record can be providedthroughout the day, week, month, or the like. Moreover, because thehealth and environmental sensors can be small and compact, the overallsize of an apparatus, such as an earpiece, can remain lightweight andcompact.

In some embodiments, the earpiece is designed to remain invisible to theoutside casual observer. The earpiece can be made of materials such assilicone or polyurethane with properties that essentially make anyportions opaque that can have external exposure. Thus, the earpiece willhave a chameleon-like quality and take on the color of the small portionof skin that it may be covering. Any small portion that remains visibleoutside the orifice of the ear will then blend with the skin color inthe area immediately adjacent to the orifice of the ear.

As the In-Ear-Canal version is intended to remain invisible to theoutside casual observer, the user of such a small device should stillhave a way to distinguish which earpiece is for left ear insertion orright ear insertion. FIG. 10A illustrates a left earpiece and FIG. 10Billustrates a comparable right earpiece. The use of a colored dot orother visible marker would compromise the “invisibility” of the product.Thus, in some embodiments, the balloon for one or both of the earpiecescan have a colored portion or have a fluid tinted that fills the balloonwhich could be used to designate intended use for a particular ear (leftor right, e.g., red for the right etc.). The balloon is in invisible tothe audience as it is worn inside the ear canal. In some embodiments,the earpiece can provide a tone and/or message once it detects movementindicative of placement of the device in the ear where the tone or audiomessage provides an indication of “left” or “right” for thecorresponding left or right earpiece. In other words, the earpiece caninstruct or “speak” to the user to let the user know that the earpieceis the “left” earpiece or “right” earpiece when the user installs thecorresponding left or right earpiece into their ear canal. If the userinstalls the left earpiece in their right ear, the user will realizethat they placed the earpiece in the wrong side when they hear the word“left” in their right ear. In some embodiments, the user may be able toreverse the functionality of the earpiece with a recognizableinstruction such as “reverse left right function” and thus avoid havingto physically switch or swap earpieces from left to right and from rightto left. Operationally, once the device detects movement it can emit asignal (acoustic, ultrasonic, LED, otherwise, etc) and await areflection of such signal to provide an indication that the product isbeing inserted or has been inserted into the canal or occluded area.Then the speech will provide an indication of left or right. Althoughthe primary form factor illustrated is a small or mini ear bud, theembodiments herein can also come in other form factors that does notnecessarily provide invisibility such as the earpiece 50 of FIGS. 11Aand 11B respectively. The earpiece 50 shown in FIG. 11A has a boommicrophone retracted and the same earpiece 50 in FIG. 11B has the boommicrophone 52 extended for intended use being nearer to a user's mouth.Note that the boom microphone 52 can also include a number of sensorspreviously mentioned herein.

In some embodiments, the earpiece can include a multicolor indicatorsuch as a multicolor light emitting diode (LED) to provide statusinformation. In some embodiments, a very small (e.g., 0.5 mm or evensmaller) tri-color LED can be mounted in an end cap of the earpiece. Insome embodiments, the LED would only be “on” meaning a color light wouldappear when the earpiece is out of the ear, such as on the chargingstation or while in your pocket. The tri-colors can indicate operationalstatus of the device and provide information such status informationinvolving battery charging, battery life, connectivity (e.g., WiFi orBluetooth status), noise level, or intelligibility for example.

In some embodiments, the earpiece can include biometric or physiologicalsensors for confirmation for identification, authentication, and/orsecure payment transactions. The data gathered from the sensors can beused to identify an individual among an existing group of known orregistered individuals. In some embodiments, the data can be used toauthenticate an individual for additional functions such as grantingadditional access to information or enabling transactions or paymentsfrom an existing account associated with the individual or authorizedfor use by the individual.

The various sensors in the earpiece can be used to build a profile ofthe user. Some sensor data may be more reliable and consistent thanothers, but generally one or more sensors for detecting motion, heartrate, voice, fingerprint, or even a tell-tale brainwave signal orprofile that may be consistently and uniquely repeated in response to aparticular stimulus can be used to confirm or authorize payment in apayment system.

In some embodiments, the earpiece can include a fingerprint detector ora gesture detector that can detect a particular predetermined pattern. Afingerprint detector can be used on an external portion of an earpieceto authenticate an individual and then

In some embodiments, the earpiece includes one or more Digital SignalProcessors (DSP) or other processors for processing the various signalsas inputs and outputs. For example, the DSP can including processing forNear Field Communication (NFC) signals, audio signals, data to and frommemory, BlueTooth 3.0 or 4.1 LE signaling, GPS signaling, WiFisignaling, power management, recharger, analog to digital operationalamplifiers for ambient and ear canal microphones, calling digitalamplifier output, accelerometer, capacitive sensors for gesture control,analog to digital converters for SAW, LED, and thermometer, andgraphical user interface control including control of LED used forstatus indication. Note that the ear canal microphone can be used as abiometric sensor as well to acquire heart and blood flow characteristicssince the placement of the module (1, 20, 70 or 80) can be placed closeto the jugular, carotid artery where a relatively clean heart signaturecan be captured since a great seal is formed using the balloon. Theballoon mitigates ambient sounds and allows for a stable and isolatedenvironment for monitoring and recording such biometric data.

The balloon also enables a clearer path for determining an ending pointfor voice recognition engines. Multi term or multi phrase queries becomeeasier since the complicating factor of ambient noise is essentiallyeliminated through the use of the balloon. Without the balloon, a voicerecognition engine would keep trying to attempt to recognize fringenoises near the user and would continue to have difficulty trying todistinguish between background noises and intended voice instructionsand queries from the user. Since there is a higher level of isolationand better correlation characteristics can be used between the user'svoice picked up from an ambient microphone and the user's voice pickedup using the ear canal microphone, the recognition of multi-terms orphrases and determining an end point when such phrases terminate willnaturally provide greater accuracy and intelligibility.

In some embodiments the monitoring module can be modular and have areplaceable dilation management system. In other words, the balloonportion of the monitoring module can be replaced and a new balloon witheither the same pre-existing configuration of sensors (or no sensors atall) can be used to replace the old balloon.

In some embodiments, the flange 74 shown in FIG. 8C can be shapeddifferently to more appropriately fit the geometry of the user's conchabowl. In this regard, the flange can have an irregular shape that coversa more significant portion of the concha bowl. The irregular shape alsoenables the user to more easily flip a “flap” of the flange to enableeasier removal of the module 80 from the user's EAC. Optionally, theflange can include protruding stem, boss, pole or other pull element toenable the user to more easily grab the module 80 during removal bygrabbing the stem, boss, or pole. Note that the flange 74 and theoverall module 80 is intended to be “invisible” from an ordinaryobserver once inserted into the EAC. Thus the module 80 is relativelysmall and may be difficult to manipulate once inserted within the EAC.The flap or stem (boss or pole) on the flange will enable easier removalof the EAC after insertion.

In some embodiments, the balloon can further be molded with carbon fiberinto the polymer material of the balloon. The carbon fiber or othermaterials can be used to mitigate radio frequency emissions orelectromagnetic emissions from the recharger system (see coil 94, FIG.8C).

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. The invention is defined by the following claims, withequivalents of the claims to be included therein.

Those with ordinary skill in the art may appreciate that the elements inthe figures are illustrated for simplicity and clarity and are notnecessarily drawn to scale. For example, the dimensions of some of theelements in the figures may be exaggerated, relative to other elements,in order to improve the understanding of the present invention.

It will be appreciated that the various steps identified and describedabove may be varied, and that the order of steps may be adapted toparticular applications of the techniques disclosed herein. All suchvariations and modifications are intended to fall within the scope ofthis disclosure. As such, the depiction and/or description of an orderfor various steps should not be understood to require a particular orderof execution for those steps, unless required by a particularapplication, or explicitly stated or otherwise clear from the context.

While the invention has been disclosed in connection with the preferredembodiments shown and described in detail, various modifications andimprovements thereon will become readily apparent to those skilled inthe art. Accordingly, the spirit and scope of the present invention isnot to be limited by the foregoing examples, but is to be understood inthe broadest sense allowable by law.

All documents referenced herein are hereby incorporated by reference.

What is claimed is:
 1. An aural iris system, comprising: a lumen; and amicro electro mechanical system (MEMS) actuator coupled on or in or tothe lumen for at least partially attenuating sound traversing throughthe lumen by selectively actuating the MEMS actuator on and off.
 2. Theaural iris system of claim 1, wherein the MEMS actuator is one of apiezoelectric micro-actuator or an electrostatic micro-actuator.
 3. Theaural iris system of claim 1, wherein the MEMS actuator is one of amagnetostrictive actuator, piezoelectric actuator, electromagneticactuator, electoactive polymer actuator, pneumatic actuator, hydraulicactuator, thermal biomorph actuator, state change actuator, shape memoryalloy or SMA actuator, parallel plate actuator, piezoelectric biomorphactuator, electrostatic relay actuator, curved electrode actuator,repulsive force actuator, solid expansion actuator, comb drive actuator,magnetic relay actuator, piezoelectric expansion actuator, externalfield actuator, thermal relay actuator, topology optimized actuator,S-shaped actuator, distributed actuator, inchworm actuator, fluidexpansion actuator, scratch drive actuator, micro-actuator,micro-actuator end effector, or impact actuator.
 4. The aural irissystem of claim 1, wherein the lumen includes a first open end and asecond open end and wherein the MEMS actuator is placed at the firstopen end or wherein the MEMS actuator is placed at the second open endor wherein the MEMS actuator is place at both the first open end and thesecond open end.
 5. The aural iris system of claim 1, wherein the MEMSactuator is self adjusting and used for habituation to compensate forocclusion effects.
 6. The aural iris system of claim 1, wherein the MEMSactuator uses a fast response time to lower overall background noiseexposure.
 7. The aural iris system of claim 1, wherein the lumenincludes an opening or an opening area with an edge and wherein the MEMSactuator blocks or displaces the opening or the opening area by using avertical displacement piston.
 8. The aural iris system of claim 1,wherein the lumen includes an opening or an opening area and wherein theMEMS actuator utilizes an end effector that blocks or displaces theopening or the opening area by using a moveable platform with one of aspherical plunger, a flat plate or a cone to transition the opening orthe opening area from a fully open position to a fully closed positionor from the fully closed position to the fully open position.
 9. Theaural iris system of claim 1, wherein the lumen includes an opening oran opening area and wherein the MEMS actuator blocks or displaces theopening or the opening area by using at least one of a throttle valve ora tilt mirror.
 10. The aural iris system of claim 9, wherein thethrottle valve or the tilt mirror is in an array of throttle valves ortilt mirrors and in a closed position when one or more each of throttlevalve members or tilt mirror members in the array of tilt mirrors remainin a horizontal position and in an open position when at least one ofthe throttle valve members or tilt mirror members rotate or swivelaround a single axis pivot point.
 11. The aural iris system of claim 1,wherein the lumen includes an opening or an opening area and wherein theMEMS actuator blocks or displaces the opening or the opening area byusing at least one tunable grating actuator or by using multiple tunablegrating actuators in a grid array.
 12. The aural iris system of claim11, wherein an aural iris or the aural iris system is in a closedposition when all tunable grating actuators are horizontally aligned andwherein the aural iris is in an open position when one or more of thetunable grating actuators is vertically displaced.
 13. The aural irissystem of claim 1, wherein the lumen includes an opening or an openingarea and wherein the MEMS actuator blocks or displaces the opening orthe opening area by using at least one horizontal displacement plateactuator or by using multiple horizontal displacement plate actuators ina grid array and wherein an aural iris of the aural iris system is in aclosed position when all horizontal displacement plate actuators arehorizontally aligned and the aural iris is in an open position when oneor more of the horizontal displacement plate actuators are horizontallydisplaced.
 14. The aural iris system of claim 1, wherein the lumenincludes an opening or an opening area and wherein the MEMS actuatorblocks or displaces the opening or the opening area by using at leastone zipping or curling actuator or by using multiple zipping or curlingactuators in a grid array and wherein an aural iris of the aural irissystem is in a closed position when all zipping or curling actuators lieflat and remain horizontally aligned and the aural iris is in an openposition when one or more of the zipping or curling actuators curl awayfrom a flat position.
 15. The aural iris system of claim 1, wherein thelumen includes an opening or an opening area and wherein the MEMSactuator blocks or displaces the opening or the opening area by using arotary vane actuator wherein an aural iris of the aural iris system isin a closed position when the rotary vane actuator covers one or moreopenings at the opening or the opening area of the lumen and the auraliris is in an open position when the rotary vane actuator rotates andleaves one or more openings exposed for acoustic transmissions.
 16. Theaural iris of claim 1, wherein the MEMS actuator controls a level or anopening size that controls an amount of acoustic sound that passesthrough the opening.
 17. The aural iris system of claim 1, wherein theaural iris system form a part of an earpiece, a headset, a headphone, anearphone, or a hearing aid.
 18. The aural iris system of claim 1,wherein the MEMS actuator selectively turns on and off in succession ata rate of at least 10 milliseconds.
 19. An aural iris, comprising: alumen; and an actuator coupled on or in or to the lumen for at leastpartially attenuating sound traversing through the lumen by selectivelyactuating the actuator on and off.
 20. The aural iris of claim 19,wherein the actuator turns on and off in succession at a rate of atleast 10 milliseconds.